ConstipationNCT04283266
Impact of a Synbiotic Containing Fructo-oligosaccharides and Bifidobacteria in Middle-aged Adults
A study testing Synbiotic in people with Constipation, run by Vesale Pharmaceutica.
Trial summary
The aim of the study is to evaluate the impact of a synbiotic containing fructo-oligosaccharides (FOS) and Bifidobacteria (VES002 LMG P-28149) on intestinal transit in middle-aged subjects characterized by a low number of defecations per week. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- Synbiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 12 Jun 2016to 31 Jan 2019
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Free and informed consent
- Healthy male and female aged 50-70 years
- Patient with ≥1 and ≤3 bowel movements per week in the month before the selection visit and in the two weeks before the enrolment visit.
- At least one in four bowel movements had to involve hard faeces or separate lumps of faeces (Bristol scale class 1 in the three months before enrolment).
Who cannot join
- Subjects who, in the 30 days before the selection visit or at the time of the visit, had taken drugs, dietary supplements or any foodstuff enhanced in or containing substances, bacteria or yeasts that might have an effect on primary and secondary outcomes.
- Such products were also prohibited throughout the study.
- Subjects on a particular diet or who were under medical treatment that in the investigator's viewpoint might interfere with the evaluation of the study criteria
- Subjects who drink more than three glasses of wine a day or two 25 cl glasses of beer a day, or one glass of spirits per day.
- Subjects who drink more than five cups of coffee per day;
- Subjects with a body mass index (BMI) of more than 30,
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- Subjects with type I or II diabetes,
- Subjects with constipation attributable to an organic or anatomical cause;
- Subjects with a history of chronic or inflammatory gastro-intestinal disease;
- Subjects with a history of digestive tract operation including bariatric surgery;
About this study
Official title: Impact of a Synbiotic Containing Fructo-oligosaccharides and Bifidobacteria on Stool Frequency and Biological Markers in Middle-aged Adults: a Randomized, Double-blind, Placebo-controlled Clinical Trial
The aim of the study is to evaluate the impact of a synbiotic containing fructo-oligosaccharides (FOS) and Bifidobacteria (VES002 LMG P-28149) on intestinal transit in middle-aged subjects characterized by a low number of defecations per week.
Read the detailed description
Middle-aged subjects, who met ROME III criteria for constipation, received daily two sachets of either synbiotic or for 5 days, then they received daily 1 sachet for the next 25 days.
The primary endpoint of this trial is to evaluate the effect of supplementation in synbiotic containing fructo-oligosaccharides (FOS) and Bifidobacteria (VES002 LMG P-28149) on intestinal transit in middle-aged subjects characterized by a few bowel movements per week. The secondary endpoints are to evaluate both clinical criteria such as changes in stool appearance, quality of life and mood, relief and satisfaction of participants; and biological criteria such as changes in markers of gut function, low-grade chronic inflammation markers and gut microbiota composition. The safety of product use and compliance are also evaluated
Synbiotic group. The dietary supplement under study was composed of fructo-oligosaccharides - FOS: 4.95 gr / sachet and Bifidobacterium animalis lactis: VES002 (LMG P-28149): 5 billion / sachet. Sachets of powder were diluted in a in 200 ml of water at room temperature to be taken before breakfast. Doses were 2 sachets per day for the first 5 days and then 1 sachet per day for the next 25 days.
Placebo group. The placebo looked strictly identical to the synbiotic and contained only excipients (60% maltodextrin / 40% sucrose). Sachets of powder were diluted in a in 200 ml of water at room temperature to be taken before breakfast. Doses were 2 sachets per day for the first 5 days and then 1 sachet per day for the next 25 days.
- Conditions
- Constipation
- Being tested
- Synbiotic, Placebo
- Keywords
- probiotics, constipation, FOS
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynbioticDietary supplement
Middle-aged subjects, who met ROME III criteria for constipation, received daily two sachets of synbiotic (Bifidobaterium animalis lactis Vesalius 002 and Fructo-Oligosaccharrides) for 5 days, then they received daily 1 sachet for the next 25 days
PlaceboDietary supplement
Middle-aged subjects, who met ROME III criteria for constipation, received daily two sachets of placebo (maltodextrin and sucrose) for 5 days, then they received daily 1 sachet for the next 25 days
| Study group | Role | What they receive |
|---|---|---|
| Synbiotic group | Active comparator | The synbiotic was composed of fructo-oligosaccharides (FOS): 4.95 g/ sachet and Bifidobacterium animalis lactis: 5 billion / sachet (n=13) Receives: Dietary Supplement: Synbiotic |
| Placebo group | Placebo comparator | A placebo was composed of maltodextrin (60%) and sucrose (40%) : 5 g /sachet (n =14) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
intestinal transit
stool frequency and consistency were investigated through daily self-assessment using the Bristol Stool Form Scale (BSFS). The BSFS classifies stools into 7 categories, including type 1, separate hard lumps, like nuts; type 2, sausage-shaped, but lumpy; type 3, like a sausage but with cracks on the surface; type 4, like a sausage or snake, smooth and soft; type 5, soft blobs with clear-cut edges; type 6, fluffy pieces with ragged edges, a mushy stool; type 7, watery, no solid pieces
Measured: daily evaluation (day-14 to day 30)
Secondary outcomes (7)
stool consistency
self-assessment using the Bristol Stool Form Scale
Measured: daily evaluation (day-14 to day 30)
evaluation of quality of life
Mental and physical wellbeing were assessed before (d-14) and after intervention (d30) through the Short-Form 12-item (SF-12) questionnaire consisting of 12 questions relating to: physical health problems, bodily pain, general health perceptions, vitality (energy/fatigue), social functioning, role limitations and general mental health (psychological distress and psychological well-being)
Measured: day 0 and day 30
mood
Mood alterations was investigated through daily self-assessment using the Brief Mood Introspection Scale (BMIS), consisting of 16 mood adjectives (Lively, Drowsy, Happy, Grouchy, Sad, Peppy, Tired, Nervous, Caring, Calm, Content, Loving, Gloomy, fed up, Jittery, Active)47. Subjects were asked to circle the phrases describing their present mood (with XX = definitely do not feel; X = do not feel; V = slightly feel; VV = definitely feel on the diverse adjectives).
Measured: daily evaluation (day-14 to day 30)
abdominal pain and intestinal discomfort
Evaluation based on VAS ( 0 - 100mm). 0 for no pain and 100 for unbearable pain
Measured: day -14 and day 30
plasma inflammatory markers (pg/ml)
Plasma cytokines (interleukin (IL)-1alpha, IL-6, IL-8, IL-10, IL-17a, monocyte chemotactic protein-1 (MCP-1), interferon (IFN) gamma and tumor necrosis factor (TNF) alpha) measured by multiplex immunoassay (Millipore, Belgium) using Luminex® xMap® technology (Biorad, Nazareth, Belgium)
Measured: day 0 and day 30
plasma gut peptides (pg/ml)
pancreatic polypeptide (PP), glucose-dependent insulinotropic peptide (GIP), leptin, ghrelin measured by multiplex immunoassay (Millipore, Belgium) using Luminex® xMap® technology (Biorad, Nazareth, Belgium)
Measured: day 0 and day 30
microbiota composition
16S rDNA profiling, targeting V1-V3 hypervariable region and sequenced on Illumina MiSeq
Measured: day 0 and day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start12 Jun 2016
- Primary completion29 Oct 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vesale Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Université Catholique de Louvain, University of Liege
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283266
- Sponsor's protocol ID
- VesalePharma
- Status last verified
- Mar 2020
- First submitted
- 12 Nov 2019
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Synbiotic Containing Fructo-oligosaccharides and Bifidobacteria on Stool Frequency and Biological Markers in Middle-aged Adults: a Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04283266
- Acronym / sponsor ID
- VesalePharma
- Conditions
- Constipation
- Keywords
- probiotics, constipation, FOS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Vesale PharmaceuticaIndustry (pharma, biotech, devices)
- Collaborators
- Université Catholique de Louvain, University of Liege
- Study start
- 12 Jun 2016 (actual)
- Primary completion
- 29 Oct 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 25 Feb 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.
The aim of the study is to evaluate the impact of a synbiotic containing fructo-oligosaccharides (FOS) and Bifidobacteria (VES002 LMG P-28149) on intestinal transit in middle-aged subjects characterized by a low number of defecations per week.
Detailed description
Middle-aged subjects, who met ROME III criteria for constipation, received daily two sachets of either synbiotic or for 5 days, then they received daily 1 sachet for the next 25 days.
The primary endpoint of this trial is to evaluate the effect of supplementation in synbiotic containing fructo-oligosaccharides (FOS) and Bifidobacteria (VES002 LMG P-28149) on intestinal transit in middle-aged subjects characterized by a few bowel movements per week. The secondary endpoints are to evaluate both clinical criteria such as changes in stool appearance, quality of life and mood, relief and satisfaction of participants; and biological criteria such as changes in markers of gut function, low-grade chronic inflammation markers and gut microbiota composition. The safety of product use and compliance are also evaluated
Synbiotic group. The dietary supplement under study was composed of fructo-oligosaccharides - FOS: 4.95 gr / sachet and Bifidobacterium animalis lactis: VES002 (LMG P-28149): 5 billion / sachet. Sachets of powder were diluted in a in 200 ml of water at room temperature to be taken before breakfast. Doses were 2 sachets per day for the first 5 days and then 1 sachet per day for the next 25 days.
Placebo group. The placebo looked strictly identical to the synbiotic and contained only excipients (60% maltodextrin / 40% sucrose). Sachets of powder were diluted in a in 200 ml of water at room temperature to be taken before breakfast. Doses were 2 sachets per day for the first 5 days and then 1 sachet per day for the next 25 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synbiotic group | Active comparator | Dietary Supplement: SynbioticThe synbiotic was composed of fructo-oligosaccharides (FOS): 4.95 g/ sachet and Bifidobacterium animalis lactis: 5 billion / sachet (n=13) |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboA placebo was composed of maltodextrin (60%) and sucrose (40%) : 5 g /sachet (n =14) |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Free and informed consent
- Healthy male and female aged 50-70 years
- Patient with ≥1 and ≤3 bowel movements per week in the month before the selection visit and in the two weeks before the enrolment visit.
- At least one in four bowel movements had to involve hard faeces or separate lumps of faeces (Bristol scale class 1 in the three months before enrolment).
Key exclusion criteria (10 listed)
- Subjects who, in the 30 days before the selection visit or at the time of the visit, had taken drugs, dietary supplements or any foodstuff enhanced in or containing substances, bacteria or yeasts that might have an effect on primary and secondary outcomes.
- Such products were also prohibited throughout the study.
- Subjects on a particular diet or who were under medical treatment that in the investigator's viewpoint might interfere with the evaluation of the study criteria
- Subjects who drink more than three glasses of wine a day or two 25 cl glasses of beer a day, or one glass of spirits per day.
- Subjects who drink more than five cups of coffee per day;
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 |
|---|---|---|
| SynbioticMiddle-aged subjects, who met ROME III criteria for constipation, received daily two sachets of synbiotic (Bifidobaterium animalis lactis Vesalius 002 and Fructo-Oligosaccharrides) for 5 days, then they received daily 1 sachet for the next 25 days | Dietary supplement | Synbiotic group |
| PlaceboMiddle-aged subjects, who met ROME III criteria for constipation, received daily two sachets of placebo (maltodextrin and sucrose) for 5 days, then they received daily 1 sachet for the next 25 days | Dietary supplement | Placebo group |
Primary outcome
intestinal transit
Time frame: daily evaluation (day-14 to day 30)
stool frequency and consistency were investigated through daily self-assessment using the Bristol Stool Form Scale (BSFS). The BSFS classifies stools into 7 categories, including type 1, separate hard lumps, like nuts; type 2, sausage-shaped, but lumpy; type 3, like a sausage but with cracks on the surface; type 4, like a sausage or snake, smooth and soft; type 5, soft blobs with clear-cut edges; type 6, fluffy pieces with ragged edges, a mushy stool; type 7, watery, no solid pieces
7 secondary outcomes
stool consistency
Time frame: daily evaluation (day-14 to day 30)
evaluation of quality of life
Time frame: day 0 and day 30
mood
Time frame: daily evaluation (day-14 to day 30)
abdominal pain and intestinal discomfort
Time frame: day -14 and day 30
plasma inflammatory markers (pg/ml)
Time frame: day 0 and day 30
plasma gut peptides (pg/ml)
Time frame: day 0 and day 30
microbiota composition
Time frame: day 0 and day 30
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 3 Apr 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Synbiotic in people with Constipation, run by Vesale Pharmaceutica.
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 4 inclusion and 10 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 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
intestinal transit (time frame: daily evaluation (day-14 to day 30)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2020.