ConstipationBIOWELLNCT03030664
Effect of L. Reuteri on Bowel Movements in Children (BIOWELL Study)
A study testing L.reuteri in people with Constipation, run by Centre Hospitalier Intercommunal Creteil at 5 sites in France.
Trial summary
A randomized, multicenter, placebo-controlled, double blind study in two parallel groups testing the efficacy of daily oral supplementation with the probiotic L.reuteri DSM17938 compared to placebo in increasing the number of spontaneous bowel movements in infants and children with functional constipation. Read more about this study
- Who is it for?
- Ages 6 months to 4 years
- Conditions the study is for
- Constipation
- What is being tested?
- L.reuteri
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Mar 2017to 30 Jul 2021
- 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 months to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 6 months up to 4 years
- Suffering from functional constipation, as defined by modified Rome III criteria for children aged 4 years or less (Hyman 2006)
- Parent(s) willingness to postpone major changes in the infant feeding mode
- Parent(s) willingness and ability to fill in diary and questionnaires
- Written informed consent from parents
- Stated availability throughout the study period
Who cannot join
- Chronic illness or major medical problem
- Gastrointestinal disease (including organic cause of constipation and dyschezia or history of severe fecalome)
- Intractable constipation (not responding to conventional treatment for more than 3 months)
- Gastrointestinal surgery (in the year before enrolment)
- Food allergy, lactose or gluten intolerance, as declared by parents
- Use of L. reuteri two weeks before randomisation and throughout the intervention period. If fed with infant formula, it cannot contain L. reuteri.
Show all 11Show fewer
- Use of antibiotics two weeks before randomisation and throughout the intervention period, both infant/child and lactating mother
- If breastfeeding, use of L reuteri by the mother 2 weeks prior to enrolment
- Conventional treatment for constipation within 2 weeks before enrolment
- Medication that influences gastrointestinal motility
- Mental or behavioral disorders as judged by the investigator
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CH Sud francilien
Corbeil-Essonnes
CHI Creteil
Créteil, 94000
Hôpital J. Monod - Pavillon Femme Mère Enfant - Le Havre
Le Havre
Hôpital Saint Vincent-de-Paul
Lille
CHU Robert Debré
Paris
About this study
Official title: Randomised Controlled Trial With Two Parallel Arms Testing the Effect of L. Reuteri on Bowel Movements in Children Aged 6 Months to 4 Years
A randomized, multicenter, placebo-controlled, double blind study in two parallel groups testing the efficacy of daily oral supplementation with the probiotic L.reuteri DSM17938 compared to placebo in increasing the number of spontaneous bowel movements in infants and children with functional constipation.
Read the detailed description
Functional constipation in infants up to 4 years of age is defined according to Rome III criteria (Hyman 2006). The diagnose must include 1 month of at least two of the following criteria: two or fewer defecations per week; at least 1 episode per week of incontinence after the acquisition of toilet skills; history of excessive stool retention; history of painful or hard bowel movements; presence of a large faecal mass in the rectum; history of large-diameter stools that may obstruct the toilet.
Accompanying symptoms may include irritability, decreased appetite and/or early satiety. The accompanying symptoms disappear immediately following passage of a large stool.
There is a growing interest for the use of probiotics in functional constipation as research suggests that probiotics could provide beneficial support in the traditional treatment arsenal although the mechanisms of actions are not completely understood.
Wu et al have demonstrated that Lactobacillus reuteri DSM 17938 may have a region-specific intestinal effect on gut motility and therefore could be beneficial in treatment of constipation
Lactobacillus reuteri DSM 17938 has shown significant favourable effects in adults (Ojetti 2014) and young children as described above (Coccorullo 2010, Olgac 2013). These studies require confirmation however. The present clinical study has been designed to strengthen the current available data that L. reuteri DSM 17938 has beneficial effects in infants and young children with functional constipation.
We hypothesize that daily oral supplementation with the probiotic Lactobacillus reuteri DSM 17938 will effectively increase the number of spontaneous bowel movements in infants/children diagnosed with functional constipation according to Rome IV.
- Conditions
- Constipation
- Being tested
- L.reuteri, Placebo
- Keywords
- constipation, Lactobacillus reuteri, probiotics
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L.reuteriDietary supplement
Also called Lactobacillus reuteri
Each day, at about the same time, the subjects will be given 5 drops (1x10^8 CFU) of the study product in connection with feeding
PlaceboDrug
Same formulation as study product, without probiotics.
| Study group | Role | What they receive |
|---|---|---|
| L.reuteri | Active comparator | probiotics: L.reuteri produced by Biogaia 5 drops per day: 10exp(8) colony forming unit will be delivered Receives: Dietary Supplement: L.reuteri |
| Placebo | Placebo comparator | Same formulation as probiotics, without active substance. 5 drops per day will be delivered Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of spontaneous bowel movements
Change in number of spontaneous bowel movements at week 4 compared to baseline evaluated by a bowel habit questionnaire (BQH)
Measured: Week 4
Secondary outcomes (13)
rescue medication
Total number of rescue medication during the intervention period
Measured: week 4
fecal retention
number of subjects with 3 or more than 3 stools per week and without fecal retention at the last week of the intervention period
Measured: week 4
weekly number of spontaneous bowel movements
weekly number of spontaneous bowel movements evaluated by the Bowel habit Questionnaire
Measured: week 1
weekly number of spontaneous bowel movements
weekly number of spontaneous bowel movements evaluated by the Bowel habit Questionnaire
Measured: week 2
weekly number of spontaneous bowel movements
weekly number of spontaneous bowel movements evaluated by the Bowel habit Questionnaire
Measured: week 3
weekly number of spontaneous bowel movements
weekly number of spontaneous bowel movements evaluated by the Bowel habit Questionnaire
Measured: week 4
weekly number of spontaneous bowel movements
weekly number of spontaneous bowel movements evaluated by the Bowel habit Questionnaire
Measured: week 8
Score of QOL
Score of quality of life measured using the PedsQL Parent family acute version
Measured: baseline
Score of QOL
Score of quality of life measured using the PedsQL Parent family acute version
Measured: week 4
Score of QOL
Score of quality of life measured using the PedsQL Parent family acute version
Measured: week 8
Pain during defecation
Score of pain during defecation measured using Hick or Wong baker faces
Measured: baseline
Pain during defecation
Score of pain during defecation measured using Hick or Wong baker faces
Measured: week 4
Pain during defecation
Score of pain during defecation measured using Hick or Wong baker faces
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start1 Mar 2017
- Primary completion30 Jun 2021
- Study completion30 Jul 2021
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 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- BioGaia AB
- Responsible party
- Principal investigator, Camille JUNG, Centre Hospitalier Intercommunal Creteil
- Investigators
- Marc BELLAICHE, MD, Principal investigator, Hopital Universitaire Robert-Debre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030664
- Sponsor's protocol ID
- BIOWELL
- Other IDs
- 2016-A00419-42
- Acronym
- BIOWELL
- Status last verified
- Jun 2022
- First submitted
- 23 Jan 2017
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jung C, Kalach N, Degas V, Jeridi Y, Bertrand V, Bellaiche M. Effect of L. reuteri on bowel movements in children aged 6 months to 4 years: A double-blind randomized controlled trial. Front Pediatr. 2022 Oct 26;10:997104. doi: 10.3389/fped.2022.997104. eCollection 2022.
PubMed 36389355
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial With Two Parallel Arms Testing the Effect of L. Reuteri on Bowel Movements in Children Aged 6 Months to 4 Years
- ClinicalTrials.gov ID
- NCT03030664
- Acronym / sponsor ID
- BIOWELL / BIOWELL
- Conditions
- Constipation
- Keywords
- constipation, Lactobacillus reuteri, probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- BioGaia AB
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 25 Jan 2017 (estimated)
- 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.
A randomized, multicenter, placebo-controlled, double blind study in two parallel groups testing the efficacy of daily oral supplementation with the probiotic L.reuteri DSM17938 compared to placebo in increasing the number of spontaneous bowel movements in infants and children with functional constipation.
Detailed description
Functional constipation in infants up to 4 years of age is defined according to Rome III criteria (Hyman 2006). The diagnose must include 1 month of at least two of the following criteria: two or fewer defecations per week; at least 1 episode per week of incontinence after the acquisition of toilet skills; history of excessive stool retention; history of painful or hard bowel movements; presence of a large faecal mass in the rectum; history of large-diameter stools that may obstruct the toilet.
Accompanying symptoms may include irritability, decreased appetite and/or early satiety. The accompanying symptoms disappear immediately following passage of a large stool.
There is a growing interest for the use of probiotics in functional constipation as research suggests that probiotics could provide beneficial support in the traditional treatment arsenal although the mechanisms of actions are not completely understood.
Wu et al have demonstrated that Lactobacillus reuteri DSM 17938 may have a region-specific intestinal effect on gut motility and therefore could be beneficial in treatment of constipation
Lactobacillus reuteri DSM 17938 has shown significant favourable effects in adults (Ojetti 2014) and young children as described above (Coccorullo 2010, Olgac 2013). These studies require confirmation however. The present clinical study has been designed to strengthen the current available data that L. reuteri DSM 17938 has beneficial effects in infants and young children with functional constipation.
We hypothesize that daily oral supplementation with the probiotic Lactobacillus reuteri DSM 17938 will effectively increase the number of spontaneous bowel movements in infants/children diagnosed with functional constipation according to Rome IV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L.reuteri | Active comparator | Dietary Supplement: L.reuteriprobiotics: L.reuteri produced by Biogaia 5 drops per day: 10exp(8) colony forming unit will be delivered |
| Placebo | Placebo comparator | Drug: PlaceboSame formulation as probiotics, without active substance. 5 drops per day will be delivered |
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age: 6 months up to 4 years
- Suffering from functional constipation, as defined by modified Rome III criteria for children aged 4 years or less (Hyman 2006)
- Parent(s) willingness to postpone major changes in the infant feeding mode
- Parent(s) willingness and ability to fill in diary and questionnaires
- Written informed consent from parents
Key exclusion criteria (11 listed)
- Chronic illness or major medical problem
- Gastrointestinal disease (including organic cause of constipation and dyschezia or history of severe fecalome)
- Intractable constipation (not responding to conventional treatment for more than 3 months)
- Gastrointestinal surgery (in the year before enrolment)
- Food allergy, lactose or gluten intolerance, as declared by parents
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 |
|---|---|---|
| L.reuteriAlso: Lactobacillus reuteriEach day, at about the same time, the subjects will be given 5 drops (1x10^8 CFU) of the study product in connection with feeding | Dietary supplement | L.reuteri |
| PlaceboSame formulation as study product, without probiotics. | Drug | Placebo |
Primary outcome
Change in number of spontaneous bowel movements
Time frame: Week 4
Change in number of spontaneous bowel movements at week 4 compared to baseline evaluated by a bowel habit questionnaire (BQH)
13 secondary outcomes
rescue medication
Time frame: week 4
fecal retention
Time frame: week 4
weekly number of spontaneous bowel movements
Time frame: week 1
weekly number of spontaneous bowel movements
Time frame: week 2
weekly number of spontaneous bowel movements
Time frame: week 3
weekly number of spontaneous bowel movements
Time frame: week 4
weekly number of spontaneous bowel movements
Time frame: week 8
Score of QOL
Time frame: baseline
Score of QOL
Time frame: week 4
Score of QOL
Time frame: week 8
Pain during defecation
Time frame: baseline
Pain during defecation
Time frame: week 4
Pain during defecation
Time frame: week 8
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 13 Jun 2022.
- Derived from this study: PubMed 36389355Jung C, Kalach N, Degas V, Jeridi Y, Bertrand V, Bellaiche M. Effect of L. reuteri on bowel movements in children aged 6 months to 4 years: A double-blind randomized controlled trial. Front Pediatr. 2022 Oct 26;10:997104. doi: 10.3389/fped.2022.997104. eCollection 2022.
- 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.
Marc BELLAICHE, MD principal investigator
Hopital Universitaire Robert-Debre
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L.reuteri in people with Constipation, run by Centre Hospitalier Intercommunal Creteil at 5 sites in France.
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 6 inclusion and 11 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 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
Change in number of spontaneous bowel movements (time frame: Week 4). 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 NCT03030664, 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 13 Jun 2022.