Infant DevelopmentPETITNCT04791956
Prebiotic EffecT InfanTs
A study testing Prebiotic in people with Infant Development and Healthy, run by Beneo-Institute at 2 sites in Spain.
Trial summary
The study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on stool consistency in infants. Read more about this study
- Who is it for?
- Ages 6 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Development, Healthy, Diet, Healthy
- What is being tested?
- Prebiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 2 sitesSpain
- Study dates
- 17 Mar 2021to Jun 2024
- 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 6 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child is healthy at the time of pre-examination
- Child was born on term or preterm (≥ 32 weeks of gestation)
- Child is aged 6-12 months at the time of pre-examination (for preterm born children (32-37 weeks of gestation), corrected age will be applied)
- Normal growth (weight and length for age between 10th and 90th percentiles, Fenton and Kim 2013)
- Child receives at least one meal per day as complementary feeding
- Child and legal guardian are able and willing to follow the study instructions
- Child is suitable for participation in the study according to the investigator/physician/study personnel
- Written informed consent is given by parent or legal guardian
Who cannot join
- No legal guardian's command of any local language
- Organic causes of defecation disorders incl. Hirschsprung disease, Spina bifida, hypothyroidism etc.
- Other metabolic or renal abnormalities or psychomotor retardation (e.g. hypotonia)
- Child has allergy to cow's milk protein or lactose intolerance
- Child has been or is currently breast-fed more than once daily (6 weeks before intervention)
- Child has mostly loose or watery stools in ≥ 50% of defecations
Show all 9Show fewer
- Use of drugs (e.g. antibiotics) influencing gastrointestinal function (6 weeks before intervention)
- Use of laxatives or pre- or probiotic supplements in the previous 4 weeks before intervention
- Child is currently involved or will be involved in another clinical or food study
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitari Sant Joan de Reus - Magatzem
Reus, 43204
Carme Rubio
- Recruiting
Hospital Universitari Joan XXIII de Tarragona - Almacén general
Tarragona, 43005
Mariona Gispert
About this study
Official title: Double-blind, Randomized Placebo-controlled Trial Investigating the Effect of Prebiotic Inulin-type Fructans on Bowel Habits of Infants
The study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on stool consistency in infants.
Read the detailed description
The fermentation of prebiotic inulin-type fructans leads to a modulation of the gut microbiota composition, in particular to a growth stimulation of bifidobacteria, and the production of organic acids like lactate and short-chain fatty acids (SCFA). The introduction of solid foods is frequently associated with harder stools which are more difficult to pass and can cause painful defecations. Subsequently, the changes in bowel habits associated with weaning and the introduction of complementary foods could be minimized by the addition of prebiotics to complementary foods and, thus, the transition from milk-feeding to family food could be facilitated.
- Conditions
- Infant Development, Healthy, Diet, Healthy
- Being tested
- Prebiotic, Placebo
- Keywords
- Microbiota, gastrointestinal health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrebioticDietary supplement
Daily intake of Inulin-type fructans from chicory
PlaceboDietary supplement
Daily intake of maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic | Experimental | Inulin-type fructans Receives: Dietary Supplement: Prebiotic |
| Placebo | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool consistency
Assessed by the parents in a continuous daily bowel diary over the study period
Measured: 4 weeks
Secondary outcomes (10)
Stool frequency
Assessed by daily parental reporting
Measured: 4 weeks
Stool colour
Assessed by the parents in a continuous daily bowel diary over the study period
Measured: 4 weeks
Stool amount
Assessed by the parents in a continuous daily bowel diary over the study period
Measured: 4 weeks
Sleep
Change in sleep behavior assessed by parental questionnaire (Brief Infant Sleep Questionnaire) at the beginning and end of the trial
Measured: 4 weeks
Stool pH
change in stool pH over a four week period
Measured: 4 weeks
stool short-chain fatty acids
change in amount and relative distribution of short-chain fatty acids in stool over a four week period
Measured: 4 weeks
Tolerance and acceptability
Tolerance and acceptability of the study products assessed by customized parental questionnaire at the end of the trial
Measured: 4 weeks
Body weight
changes in body weight (kg) assessed by an investigator
Measured: 4 weeks
Body height
changes in body height (m) assessed by an investigator
Measured: 4 weeks
Faecal Microbiota
Stool samples will be analysed by appropriate molecular biological methods like 16S rRNA gene sequencing to gain insight into the composition of the gut microbiota.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start17 Mar 2021
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant DevelopmentStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beneo-Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitari Sant Joan de Reus, Hospital de Tarragona Joan XXIII, Institut Investigacio Sanitaria Pere Virgili
- Responsible party
- Sponsor
- Investigators
- Ricardo Closa Monasterolo, Phd, MD, Principal investigator, Paediatrics Unit, University Hospital Joan XXIII, Tarragona, Spain. Paediatrics Research Unit on Nutrition and Human Development, Universitat Rovira i Virgili, Reus, SpainJoaquin Escribano Subias, PhD, MD, Principal investigator, Paediatrics Unit, University Hospital Sant Joan, Reus, Spain. Paediatrics Research Unit on Nutrition and Human Development, Universitat Rovira i Virgili, Reus, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791956
- Sponsor's protocol ID
- 20018m-jhr
- Acronym
- PETIT
- Status last verified
- Apr 2023
- First submitted
- 5 Mar 2021
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Closa-Monasterolo R, Ferre N, Castillejo-DeVillasante G, Luque V, Gispert-Llaurado M, Zaragoza-Jordana M, Theis S, Escribano J. The use of inulin-type fructans improves stool consistency in constipated children. A randomised clinical trial: pilot study. Int J Food Sci Nutr. 2017 Aug;68(5):587-594. doi: 10.1080/09637486.2016.1263605. Epub 2016 Dec 8.
PubMed 27931142
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized Placebo-controlled Trial Investigating the Effect of Prebiotic Inulin-type Fructans on Bowel Habits of Infants
- ClinicalTrials.gov ID
- NCT04791956
- Acronym / sponsor ID
- PETIT / 20018m-jhr
- Conditions
- Infant Development, Healthy, Diet, Healthy
- Keywords
- Microbiota, gastrointestinal health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Beneo-InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Universitari Sant Joan de Reus, Hospital de Tarragona Joan XXIII, Institut Investigacio Sanitaria Pere Virgili
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 10 Mar 2021 (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 study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on stool consistency in infants.
Detailed description
The fermentation of prebiotic inulin-type fructans leads to a modulation of the gut microbiota composition, in particular to a growth stimulation of bifidobacteria, and the production of organic acids like lactate and short-chain fatty acids (SCFA). The introduction of solid foods is frequently associated with harder stools which are more difficult to pass and can cause painful defecations. Subsequently, the changes in bowel habits associated with weaning and the introduction of complementary foods could be minimized by the addition of prebiotics to complementary foods and, thus, the transition from milk-feeding to family food could be facilitated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prebiotic | Experimental | Dietary Supplement: PrebioticInulin-type fructans |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Child is healthy at the time of pre-examination
- Child was born on term or preterm (≥ 32 weeks of gestation)
- Child is aged 6-12 months at the time of pre-examination (for preterm born children (32-37 weeks of gestation), corrected age will be applied)
- Normal growth (weight and length for age between 10th and 90th percentiles, Fenton and Kim 2013)
- Child receives at least one meal per day as complementary feeding
Key exclusion criteria (9 listed)
- No legal guardian's command of any local language
- Organic causes of defecation disorders incl. Hirschsprung disease, Spina bifida, hypothyroidism etc.
- Other metabolic or renal abnormalities or psychomotor retardation (e.g. hypotonia)
- Child has allergy to cow's milk protein or lactose intolerance
- Child has been or is currently breast-fed more than once daily (6 weeks before intervention)
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 |
|---|---|---|
| PrebioticDaily intake of Inulin-type fructans from chicory | Dietary supplement | Prebiotic |
| PlaceboDaily intake of maltodextrin | Dietary supplement | Placebo |
Primary outcome
Stool consistency
Time frame: 4 weeks
Assessed by the parents in a continuous daily bowel diary over the study period
10 secondary outcomes
Stool frequency
Time frame: 4 weeks
Stool colour
Time frame: 4 weeks
Stool amount
Time frame: 4 weeks
Sleep
Time frame: 4 weeks
Stool pH
Time frame: 4 weeks
stool short-chain fatty acids
Time frame: 4 weeks
Tolerance and acceptability
Time frame: 4 weeks
Body weight
Time frame: 4 weeks
Body height
Time frame: 4 weeks
Faecal Microbiota
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Background: PubMed 27931142Closa-Monasterolo R, Ferre N, Castillejo-DeVillasante G, Luque V, Gispert-Llaurado M, Zaragoza-Jordana M, Theis S, Escribano J. The use of inulin-type fructans improves stool consistency in constipated children. A randomised clinical trial: pilot study. Int J Food Sci Nutr. 2017 Aug;68(5):587-594. doi: 10.1080/09637486.2016.1263605. Epub 2016 Dec 8.
- 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.
Ricardo Closa Monasterolo, Phd, MD principal investigator
Paediatrics Unit, University Hospital Joan XXIII, Tarragona, Spain. Paediatrics Research Unit on Nutrition and Human Development, Universitat Rovira i Virgili, Reus, Spain
Joaquin Escribano Subias, PhD, MD principal investigator
Paediatrics Unit, University Hospital Sant Joan, Reus, Spain. Paediatrics Research Unit on Nutrition and Human Development, Universitat Rovira i Virgili, Reus, Spain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic in people with Infant Development and Healthy, run by Beneo-Institute at 2 sites in Spain.
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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephan Theis, PhD (+49 6359 803 287, stephan.theis@beneo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool consistency (time frame: 4 weeks). 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 NCT04791956, which also lists 1 linked publication.
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 12 Apr 2023.