ConstipationPDS-08™NCT04534036
Tolerability and Functional Assessment of a Novel Children's Synbiotic
A study testing PDS-08 in people with Constipation and Signs and Symptoms, run by Seed Health at 1 site in United States.
Trial summary
Recent data support the use of specific probiotic strains in a pediatric population. However, given the wide number of commercial products available, and contradictory data in the literature, healthcare providers and consumers are uncertain about whether or not to use probiotics in children and which one(s) to choose. Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation, Signs and Symptoms, Digestive Signs and Symptoms
- What is being tested?
- PDS-08
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2020to 10 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The parent(s) or direct relative guardian(s) of the participant must be willing and able to give informed assent/consent for participation in the study.
- Participant must be in good health as determined from participant's medical history.
- Males \& Females between 3-17 years old.
- Normal weight or overweight (BMI between the age- and sex-specific 5th percentile and 95th percentile).
- Children with constipation (defined as less than 4 bowel movements per week) and/or baseline Bristol Stool Form Scale score of 1 or 2.
- Participant's parent(s) must be willing and able (in the PI's opinion) to comply with all study requirements.
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- Children with healthy skin or eczema and/or acne.
- Females of childbearing potential (post-menarche) and/or their parents must make a written and/or verbal statement prior to randomization indicating that they are not pregnant and adhere to a pregnancy prevention method (abstinence or barrier method plus spermicidal foam or oral or implanted contraceptive).
- Consistent use of medications not listed in the exclusion criteria.
- Participant is under the care of a parent or direct relative guardian.
Who cannot join
- Underweight (BMI<5th percentile for age) or obese (BMI above the 95th percentile on the Centers for Disease Control and Prevention growth charts).
- Participants are taking, and plan to continue taking, medications (including over the counter (OTC), such as simethicone for gas), home remedies (such as juice for constipation), herbal preparations, or rehydration fluids that might affect GI tolerance.
- Participants taking laxatives.
- Participants using probiotics, antibiotics, or antifungals during the course of the study or within the past 1 month.
- Participants receiving administration of any investigational drug within the past 1 month.
- Participants who are pregnant, lactating, or planning a pregnancy during the course of the study.
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- Participants with compromised immunity.
- Participants with GI disease (e.g., inflammatory bowel disease, celiac disease, prior intestinal resection, SIBO/small intestinal bacterial growth, irritable bowel syndrome, functional abdominal pain, or lactose intolerance).
- Participants are taking medication such as antipsychotics, antidepressants, mood stabilizers, medications for Attention Deficit Hyperactivity Disorder, anti-anxiety medications (Anxiolytics), or related medication.
- Participants on medically prescribed diets or supplements other than a standard multivitamin.
- Participants with plans to travel outside the USA during the study. Alcohol or drug abuse.
- Participants using any oral over the counter or prescription medications for acne or atopic dermatitis.
- Participants who have recently tested positive for COVID-19 or who live with adults with an active COVID-19 infection.
- Participants are under the care of someone other than a parent or direct relative guardian.
Trial locations and contacts
1 site in 1 country.
United States1 site
Curebase, Inc.
San Francisco, California, 94103-3627
About this study
Official title: A 12-week Randomized, Double-Blind Controlled Trial to Evaluate the Tolerability and Gastrointestinal Response of a Novel, Multi-Strain Synbiotic (PDS-08™) in Children Ages 3-17
Recent data support the use of specific probiotic strains in a pediatric population. However, given the wide number of commercial products available, and contradictory data in the literature, healthcare providers and consumers are uncertain about whether or not to use probiotics in children and which one(s) to choose. While much progress has been made in understanding the gastrointestinal microbiota and its role in the balanced development of the infant immune system, the tolerability and efficacy of introducing beneficial microbes into the pediatric gastrointestinal tract remain underexplored.
The purpose of this study is to investigate the effect of a 9 strain synbiotic consortium comprised of strains with previous pediatric clinical data for use in modulating airway sensitivity, gastrointestinal discomfort, dermatological inflammation, and reduction in the duration and severity of upper respiratory tract infections in a pediatric population.
Read the detailed description
During infancy and childhood, environmental factors including the maternal vaginal and skin microbiomes, breast milk microbiota, breast milk, geographic location, and use of antibiotics will exert significant influence over the offspring's microbiota and have a determinant impact on their health later in life. Unfavorable environmental exposures, coupled with an immature immune system in early life can, therefore, confer suboptimal immune responses that can lead to the development of extra-gastrointestinal conditions such as allergic rhinitis, asthma, and atopic dermatitis-which affects 15-20% of the world's population. Furthermore, while the indiscriminate use of antibiotics has decreased, they remain standard-of-care for most childhood infections, and unfortunately, often result in short- or long-term disruption of the patient's microbiome.
Constipation is a common childhood gastrointestinal disorder, with a worldwide prevalence between 0.7-29.6%. Its etiology is multifactorial and usually not due to underlying conditions. Few studies have explored the implications of the intestinal or fecal microbiota in childhood constipation, yet some have shown benefits of various probiotic compositions in reducing transit time and improving bowel movement frequency. Dysbiosis of the gut microbiome may play an important role in functional constipation.
PDS-08™ is a novel synbiotic, comprised of nine probiotic bacterial strains and fructooligosaccharide with inulin (FOS-inulin) as a prebiotic. A synbiotic is defined as a probiotic ("live microorganisms that, when administered in adequate amounts, confer a health benefit on the host") plus an established prebiotic ("a substrate that is selectively utilized by host microorganisms conferring a health benefit")-or, an untested live microbe co-administered with a substrate that it selectively utilizes. The selected probiotics and prebiotic in the PDS-08 formulation have shown to improve antibiotic-associated diarrhea, gastrointestinal and respiratory tract infections, allergic rhinitis, atopic dermatitis, irritable bowel syndrome (IBS) symptoms, and/or microbiota modulation. The positive outcomes of these respective studies warrants further investigation of the strains as part of a probiotic consortium with the potential to modulate the microbiota, regulate dysbiosis, and confer a benefit to host health. There is a need for additional systematic studies on probiotic administration in pediatric populations, with a focus on measuring shifts in the fecal microbiota and markers of gut health and function. Therefore, the objective of this study is to assess the efficacy, tolerability, and safety of a novel synbiotic in healthy children with occasional constipation, over 12 weeks, as compared to a sensory-matched placebo.
This is a randomized, 12-week study to compare the efficacy and tolerability of PDS-08 in a cohort of 100 healthy children with constipation. 50 subjects will receive PDS-08™ over 12 weeks, and 50 subjects will receive a placebo. Subjects will provide stool samples at baseline and week 12. Safety is a paramount concern in the study design and will be monitored carefully throughout the study. Parents or direct relative guardians of study subjects will receive extensive education on synbiotic use.
- Conditions
- Constipation, Signs and Symptoms, Digestive Signs and Symptoms, Infrequent or Difficult Evacuation
- Being tested
- PDS-08, Placebo
- Medical subject headings
- Constipation, Signs and Symptoms, Signs and Symptoms, Digestive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDS-08Dietary supplement
PDS-08 is a novel synbiotic comprised of nine probiotic bacterial strains and FOS-inulin as a prebiotic.
PlaceboOther
Placebo sachets will contain potato or tapioca maltodextrin.
| Study group | Role | What they receive |
|---|---|---|
| Multi-Strain Synbiotic (PDS-08) | Active comparator | PDS-08 is a rationally defined microbial consortium consisting of 9 strains, with FOS-inulin as prebiotic. Participants will be instructed to take 1 sachet daily for the duration of the trial. Receives: Dietary Supplement: PDS-08 |
| Placebo | Placebo comparator | Placebo sachets for PDS-08 will contain potato or tapioca maltodextrin matched for color and texture. Participants will be instructed to take 1 sachet daily for the duration of the trial. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who are spontaneous bowel movement responders, defined as having an average of ≥ 4 complete spontaneous bowel movements (CSBMs) per week and an average increase of ≥ 1 CSBM from baseline, by age group: 3-6, 7-12, 13-17 years.
Assessed as the change from baseline and compared to placebo for the continuous variable estimated using a linear mixed model.
Measured: Baseline-Day 84
Secondary outcomes (8)
Average increase from baseline of Bristol Stool Form Scale (BSFS) score by ≥ 1 point (stool characterized as an increase to either type 2 or 3 or 4) in the intervention group, compared to the placebo group.
Assessed by daily stool characteristics reported using the seven-point ordinal BSFS score. The BSFS classifies human stool into seven types and scores them accordingly. Type 1: Separate hard lumps (hard to pass) Type 2: Sausage-shaped and lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid. Types 1 and 2 indicate constipation, with 3 through 5 represent the ideal stool form, and 6 and 7 tend towards diarrhea.
For a given assessment week, the weekly stool consistency is defined as the sum of non-missing stool consistency score for spontaneous bowel movements during that week divided by the number of non-missing stool consistency scores for spontaneous bowel movements during that week. The parameter will be analyzed using a linear mixed model.
Measured: Baseline-Day 84
Decrease of ≥ 10% in time spent emptying bowel from beginning to end of bowel movement, compared to baseline.
Measured: Baseline-Day 84
Changes in subjective assessment of gut tolerability as reported by parents or direct relative guardians, indicated by sustained (longer than 7 days of) abdominal pain, severe bloating, heartburn, acid reflux, or indigestion.
Assessed by online daily symptom-tracking of stool-quality, regularity, ease of expulsion, bloating, and flatulence.
Measured: Baseline-Day 84
Maintenance or increase of diversity within the PDS-08 treatment group.
Microbiota composition will be identified through fecal samples for total genomic DNA extraction in participants supplemented with PDS-08 or placebo. Metagenomic sequencing will yield a total observable species count and maintenance will be defined as within 20% of the total observed species count when compared to baseline.
Measured: Baseline-Day 84
Significant increase in QoL measured by the KINDL questionnaire with respect to mean change from baseline score (p<0.05).
Measured: Baseline-Day 84
Exploratory: number of respiratory tract infections in the PDS-08 group compared to placebo.
Measured: Baseline-Day 84
Exploratory: number and percent of participants with reduction in number of acne lesions from baseline as measured by global count of blemishes.
Measured: Baseline-Day 84
Exploratory outcomes: changes in fecal calprotectin, histamine, bacterial enzymes (β-glucosidase and β-glucuronidase), β-defensin (hBD2) and short chain fatty acids in treatment group compared to the placebo group.
Measured: Baseline-Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start13 Aug 2020
- Primary completion14 Jan 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seed Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Curebase Inc.
- Responsible party
- Sponsor
- Investigators
- Charles Baum, MD, Principal investigator, Encore Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534036
- Sponsor's protocol ID
- PDS-08
- Acronym
- PDS-08™
- Status last verified
- Oct 2022
- First submitted
- 25 Aug 2020
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Candela M, Biagi E, Maccaferri S, Turroni S, Brigidi P. Intestinal microbiota is a plastic factor responding to environmental changes. Trends Microbiol. 2012 Aug;20(8):385-91. doi: 10.1016/j.tim.2012.05.003. Epub 2012 Jun 5.
PubMed 22672911Jost T, Lacroix C, Braegger C, Chassard C. Assessment of bacterial diversity in breast milk using culture-dependent and culture-independent approaches. Br J Nutr. 2013 Oct;110(7):1253-62. doi: 10.1017/S0007114513000597. Epub 2013 Mar 14.
PubMed 23507238Morrow AL, Ruiz-Palacios GM, Altaye M, Jiang X, Guerrero ML, Meinzen-Derr JK, Farkas T, Chaturvedi P, Pickering LK, Newburg DS. Human milk oligosaccharides are associated with protection against diarrhea in breast-fed infants. J Pediatr. 2004 Sep;145(3):297-303. doi: 10.1016/j.jpeds.2004.04.054.
PubMed 15343178Schuez-Havupalo L, Toivonen L, Karppinen S, Kaljonen A, Peltola V. Daycare attendance and respiratory tract infections: a prospective birth cohort study. BMJ Open. 2017 Sep 5;7(9):e014635. doi: 10.1136/bmjopen-2016-014635.
PubMed 28877939Ngurah G, Putra S, Suraatmaja S, Ketut I, Aryasa N. Effect of probiotics supplementation on acute diarrhea in infants: a randomized double blind clinical trial. Paediatrica Indonesiana. 2007;47.
Ege MJ, Mayer M, Normand AC, Genuneit J, Cookson WO, Braun-Fahrlander C, Heederik D, Piarroux R, von Mutius E; GABRIELA Transregio 22 Study Group. Exposure to environmental microorganisms and childhood asthma. N Engl J Med. 2011 Feb 24;364(8):701-9. doi: 10.1056/NEJMoa1007302.
PubMed 21345099Avena-Woods C. Overview of atopic dermatitis. Am J Manag Care. 2017 Jun;23(8 Suppl):S115-S123.
PubMed 28978208Gensollen T, Blumberg RS. Correlation between early-life regulation of the immune system by microbiota and allergy development. J Allergy Clin Immunol. 2017 Apr;139(4):1084-1091. doi: 10.1016/j.jaci.2017.02.011.
PubMed 28390575Vaz LE, Kleinman KP, Raebel MA, Nordin JD, Lakoma MD, Dutta-Linn MM, Finkelstein JA. Recent trends in outpatient antibiotic use in children. Pediatrics. 2014 Mar;133(3):375-85. doi: 10.1542/peds.2013-2903. Epub 2014 Feb 2.
PubMed 24488744Wistrom J, Norrby SR, Myhre EB, Eriksson S, Granstrom G, Lagergren L, Englund G, Nord CE, Svenungsson B. Frequency of antibiotic-associated diarrhoea in 2462 antibiotic-treated hospitalized patients: a prospective study. J Antimicrob Chemother. 2001 Jan;47(1):43-50. doi: 10.1093/jac/47.1.43.
PubMed 11152430van den Berg MM, Benninga MA, Di Lorenzo C. Epidemiology of childhood constipation: a systematic review. Am J Gastroenterol. 2006 Oct;101(10):2401-9. doi: 10.1111/j.1572-0241.2006.00771.x.
PubMed 17032205Sadeghzadeh M, Rabieefar A, Khoshnevisasl P, Mousavinasab N, Eftekhari K. The effect of probiotics on childhood constipation: a randomized controlled double blind clinical trial. Int J Pediatr. 2014;2014:937212. doi: 10.1155/2014/937212. Epub 2014 Apr 9.
PubMed 24812563Bu LN, Chang MH, Ni YH, Chen HL, Cheng CC. Lactobacillus casei rhamnosus Lcr35 in children with chronic constipation. Pediatr Int. 2007 Aug;49(4):485-90. doi: 10.1111/j.1442-200X.2007.02397.x.
PubMed 17587273de Meij TG, de Groot EF, Eck A, Budding AE, Kneepkens CM, Benninga MA, van Bodegraven AA, Savelkoul PH. Characterization of Microbiota in Children with Chronic Functional Constipation. PLoS One. 2016 Oct 19;11(10):e0164731. doi: 10.1371/journal.pone.0164731. eCollection 2016.
PubMed 27760208Zhu L, Liu W, Alkhouri R, Baker RD, Bard JE, Quigley EM, Baker SS. Structural changes in the gut microbiome of constipated patients. Physiol Genomics. 2014 Sep 15;46(18):679-86. doi: 10.1152/physiolgenomics.00082.2014. Epub 2014 Jul 29.
PubMed 25073603
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week Randomized, Double-Blind Controlled Trial to Evaluate the Tolerability and Gastrointestinal Response of a Novel, Multi-Strain Synbiotic (PDS-08™) in Children Ages 3-17
- ClinicalTrials.gov ID
- NCT04534036
- Acronym / sponsor ID
- PDS-08™ / PDS-08
- Conditions
- Constipation, Signs and Symptoms, Digestive Signs and Symptoms, Infrequent or Difficult Evacuation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Seed HealthIndustry (pharma, biotech, devices)
- Collaborators
- Curebase Inc.
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recent data support the use of specific probiotic strains in a pediatric population. However, given the wide number of commercial products available, and contradictory data in the literature, healthcare providers and consumers are uncertain about whether or not to use probiotics in children and which one(s) to choose. While much progress has been made in understanding the gastrointestinal microbiota and its role in the balanced development of the infant immune system, the tolerability and efficacy of introducing beneficial microbes into the pediatric gastrointestinal tract remain underexplored.
The purpose of this study is to investigate the effect of a 9 strain synbiotic consortium comprised of strains with previous pediatric clinical data for use in modulating airway sensitivity, gastrointestinal discomfort, dermatological inflammation, and reduction in the duration and severity of upper respiratory tract infections in a pediatric population.
Detailed description
During infancy and childhood, environmental factors including the maternal vaginal and skin microbiomes, breast milk microbiota, breast milk, geographic location, and use of antibiotics will exert significant influence over the offspring's microbiota and have a determinant impact on their health later in life. Unfavorable environmental exposures, coupled with an immature immune system in early life can, therefore, confer suboptimal immune responses that can lead to the development of extra-gastrointestinal conditions such as allergic rhinitis, asthma, and atopic dermatitis-which affects 15-20% of the world's population. Furthermore, while the indiscriminate use of antibiotics has decreased, they remain standard-of-care for most childhood infections, and unfortunately, often result in short- or long-term disruption of the patient's microbiome.
Constipation is a common childhood gastrointestinal disorder, with a worldwide prevalence between 0.7-29.6%. Its etiology is multifactorial and usually not due to underlying conditions. Few studies have explored the implications of the intestinal or fecal microbiota in childhood constipation, yet some have shown benefits of various probiotic compositions in reducing transit time and improving bowel movement frequency. Dysbiosis of the gut microbiome may play an important role in functional constipation.
PDS-08™ is a novel synbiotic, comprised of nine probiotic bacterial strains and fructooligosaccharide with inulin (FOS-inulin) as a prebiotic. A synbiotic is defined as a probiotic ("live microorganisms that, when administered in adequate amounts, confer a health benefit on the host") plus an established prebiotic ("a substrate that is selectively utilized by host microorganisms conferring a health benefit")-or, an untested live microbe co-administered with a substrate that it selectively utilizes. The selected probiotics and prebiotic in the PDS-08 formulation have shown to improve antibiotic-associated diarrhea, gastrointestinal and respiratory tract infections, allergic rhinitis, atopic dermatitis, irritable bowel syndrome (IBS) symptoms, and/or microbiota modulation. The positive outcomes of these respective studies warrants further investigation of the strains as part of a probiotic consortium with the potential to modulate the microbiota, regulate dysbiosis, and confer a benefit to host health. There is a need for additional systematic studies on probiotic administration in pediatric populations, with a focus on measuring shifts in the fecal microbiota and markers of gut health and function. Therefore, the objective of this study is to assess the efficacy, tolerability, and safety of a novel synbiotic in healthy children with occasional constipation, over 12 weeks, as compared to a sensory-matched placebo.
This is a randomized, 12-week study to compare the efficacy and tolerability of PDS-08 in a cohort of 100 healthy children with constipation. 50 subjects will receive PDS-08™ over 12 weeks, and 50 subjects will receive a placebo. Subjects will provide stool samples at baseline and week 12. Safety is a paramount concern in the study design and will be monitored carefully throughout the study. Parents or direct relative guardians of study subjects will receive extensive education on synbiotic use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-Strain Synbiotic (PDS-08) | Active comparator | Dietary Supplement: PDS-08PDS-08 is a rationally defined microbial consortium consisting of 9 strains, with FOS-inulin as prebiotic. Participants will be instructed to take 1 sachet daily for the duration of the trial. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo sachets for PDS-08 will contain potato or tapioca maltodextrin matched for color and texture. Participants will be instructed to take 1 sachet daily for the duration of the trial. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- The parent(s) or direct relative guardian(s) of the participant must be willing and able to give informed assent/consent for participation in the study.
- Participant must be in good health as determined from participant's medical history.
- Males \& Females between 3-17 years old.
- Normal weight or overweight (BMI between the age- and sex-specific 5th percentile and 95th percentile).
- Children with constipation (defined as less than 4 bowel movements per week) and/or baseline Bristol Stool Form Scale score of 1 or 2.
Key exclusion criteria (14 listed)
- Underweight (BMI<5th percentile for age) or obese (BMI above the 95th percentile on the Centers for Disease Control and Prevention growth charts).
- Participants are taking, and plan to continue taking, medications (including over the counter (OTC), such as simethicone for gas), home remedies (such as juice for constipation), herbal preparations, or rehydration fluids that might affect GI tolerance.
- Participants taking laxatives.
- Participants using probiotics, antibiotics, or antifungals during the course of the study or within the past 1 month.
- Participants receiving administration of any investigational drug within the past 1 month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDS-08PDS-08 is a novel synbiotic comprised of nine probiotic bacterial strains and FOS-inulin as a prebiotic. | Dietary supplement | Multi-Strain Synbiotic (PDS-08) |
| PlaceboPlacebo sachets will contain potato or tapioca maltodextrin. | Other | Placebo |
Primary outcome
Percentage of participants who are spontaneous bowel movement responders, defined as having an average of ≥ 4 complete spontaneous bowel movements (CSBMs) per week and an average increase of ≥ 1 CSBM from baseline, by age group: 3-6, 7-12, 13-17 years.
Time frame: Baseline-Day 84
Assessed as the change from baseline and compared to placebo for the continuous variable estimated using a linear mixed model.
8 secondary outcomes
Average increase from baseline of Bristol Stool Form Scale (BSFS) score by ≥ 1 point (stool characterized as an increase to either type 2 or 3 or 4) in the intervention group, compared to the placebo group.
Time frame: Baseline-Day 84
Decrease of ≥ 10% in time spent emptying bowel from beginning to end of bowel movement, compared to baseline.
Time frame: Baseline-Day 84
Changes in subjective assessment of gut tolerability as reported by parents or direct relative guardians, indicated by sustained (longer than 7 days of) abdominal pain, severe bloating, heartburn, acid reflux, or indigestion.
Time frame: Baseline-Day 84
Maintenance or increase of diversity within the PDS-08 treatment group.
Time frame: Baseline-Day 84
Significant increase in QoL measured by the KINDL questionnaire with respect to mean change from baseline score (p<0.05).
Time frame: Baseline-Day 84
Exploratory: number of respiratory tract infections in the PDS-08 group compared to placebo.
Time frame: Baseline-Day 84
Exploratory: number and percent of participants with reduction in number of acne lesions from baseline as measured by global count of blemishes.
Time frame: Baseline-Day 84
Exploratory outcomes: changes in fecal calprotectin, histamine, bacterial enzymes (β-glucosidase and β-glucuronidase), β-defensin (hBD2) and short chain fatty acids in treatment group compared to the placebo group.
Time frame: Baseline-Day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Background: PubMed 22672911Candela M, Biagi E, Maccaferri S, Turroni S, Brigidi P. Intestinal microbiota is a plastic factor responding to environmental changes. Trends Microbiol. 2012 Aug;20(8):385-91. doi: 10.1016/j.tim.2012.05.003. Epub 2012 Jun 5.
- Background: PubMed 23507238Jost T, Lacroix C, Braegger C, Chassard C. Assessment of bacterial diversity in breast milk using culture-dependent and culture-independent approaches. Br J Nutr. 2013 Oct;110(7):1253-62. doi: 10.1017/S0007114513000597. Epub 2013 Mar 14.
- Background: PubMed 15343178Morrow AL, Ruiz-Palacios GM, Altaye M, Jiang X, Guerrero ML, Meinzen-Derr JK, Farkas T, Chaturvedi P, Pickering LK, Newburg DS. Human milk oligosaccharides are associated with protection against diarrhea in breast-fed infants. J Pediatr. 2004 Sep;145(3):297-303. doi: 10.1016/j.jpeds.2004.04.054.
- Background: PubMed 28877939Schuez-Havupalo L, Toivonen L, Karppinen S, Kaljonen A, Peltola V. Daycare attendance and respiratory tract infections: a prospective birth cohort study. BMJ Open. 2017 Sep 5;7(9):e014635. doi: 10.1136/bmjopen-2016-014635.
- BackgroundNgurah G, Putra S, Suraatmaja S, Ketut I, Aryasa N. Effect of probiotics supplementation on acute diarrhea in infants: a randomized double blind clinical trial. Paediatrica Indonesiana. 2007;47.
- Background: PubMed 21345099Ege MJ, Mayer M, Normand AC, Genuneit J, Cookson WO, Braun-Fahrlander C, Heederik D, Piarroux R, von Mutius E; GABRIELA Transregio 22 Study Group. Exposure to environmental microorganisms and childhood asthma. N Engl J Med. 2011 Feb 24;364(8):701-9. doi: 10.1056/NEJMoa1007302.
- Background: PubMed 28978208Avena-Woods C. Overview of atopic dermatitis. Am J Manag Care. 2017 Jun;23(8 Suppl):S115-S123.
- Background: PubMed 28390575Gensollen T, Blumberg RS. Correlation between early-life regulation of the immune system by microbiota and allergy development. J Allergy Clin Immunol. 2017 Apr;139(4):1084-1091. doi: 10.1016/j.jaci.2017.02.011.
- Background: PubMed 24488744Vaz LE, Kleinman KP, Raebel MA, Nordin JD, Lakoma MD, Dutta-Linn MM, Finkelstein JA. Recent trends in outpatient antibiotic use in children. Pediatrics. 2014 Mar;133(3):375-85. doi: 10.1542/peds.2013-2903. Epub 2014 Feb 2.
- Background: PubMed 11152430Wistrom J, Norrby SR, Myhre EB, Eriksson S, Granstrom G, Lagergren L, Englund G, Nord CE, Svenungsson B. Frequency of antibiotic-associated diarrhoea in 2462 antibiotic-treated hospitalized patients: a prospective study. J Antimicrob Chemother. 2001 Jan;47(1):43-50. doi: 10.1093/jac/47.1.43.
- Background: PubMed 17032205van den Berg MM, Benninga MA, Di Lorenzo C. Epidemiology of childhood constipation: a systematic review. Am J Gastroenterol. 2006 Oct;101(10):2401-9. doi: 10.1111/j.1572-0241.2006.00771.x.
- Background: PubMed 24812563Sadeghzadeh M, Rabieefar A, Khoshnevisasl P, Mousavinasab N, Eftekhari K. The effect of probiotics on childhood constipation: a randomized controlled double blind clinical trial. Int J Pediatr. 2014;2014:937212. doi: 10.1155/2014/937212. Epub 2014 Apr 9.
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Baum, MD principal investigator
Encore Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PDS-08 in people with Constipation and Signs and Symptoms, run by Seed Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who are spontaneous bowel movement responders, defined as having an average of ≥ 4 complete spontaneous bowel movements (CSBMs) per week and an average increase of ≥ 1 CSBM from baseline, by age group: 3-6, 7-12, 13-17 years. (time frame: Baseline-Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04534036, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.