Functional ConstipationNCT07536698
Co-supplementation With Bifidobacterium Longum W11 and Colopectin for Maintenance Therapy in Children With Functional Constipation
A study testing Bifidobacterium longum W11 (Bowell®) + Colopectin (Colopectin®) in people with Functional Constipation, run by Liaquat University of Medical & Health Sciences.
Trial summary
Functional constipation is a common condition in children and often requires prolonged maintenance treatment with macrogol. This randomized, double-blind, placebo-controlled trial will evaluate whether co-supplementation with Bifidobacterium longum W11 and Colopectin can support maintenance therapy in children with… Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Functional Constipation
- What is being tested?
- Bifidobacterium longum W11 (Bowell®) + Colopectin (Colopectin®)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 17 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2 to 6 years
- Diagnosis of functional constipation
- Receiving maintenance therapy with macrogol for at least 3 months
- Candidates for weaning from macrogol therapy
Who cannot join
- Children with intestinal meteorism or flatulence
- Children diagnosed with organic constipation
- History of previous abdominal surgery
- Children with frailty or disabilities
- Presence of other organ diseases or syndromes
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Dr Amjad Khan, DPhil contact
About this study
Official title: Efficacy of Co-supplementation With Bifidobacterium Longum W11 and Colopectin in the Maintenance Therapy of Children With Functional Constipation: A Randomized Double-Blind Placebo-Controlled Trial
Functional constipation is a common condition in children and often requires prolonged maintenance treatment with macrogol. This randomized, double-blind, placebo-controlled trial will evaluate whether co-supplementation with Bifidobacterium longum W11 and Colopectin can support maintenance therapy in children with functional constipation who are receiving macrogol and are candidates for weaning. Participants aged 2 to 6 years will be randomized to receive either the active supplementation or placebo once daily for 4 weeks, followed by 4 weeks of follow-up after treatment discontinuation. The study will assess persistence of constipation after macrogol discontinuation, as well as stool consistency, distress during evacuation, soiling episodes, and treatment compliance.
Read the detailed description
Functional constipation is one of the most common gastrointestinal disorders in childhood and is frequently associated with painful or infrequent defecation, stool retention, and reduced quality of life. In many children, maintenance treatment with macrogol is required for prolonged periods, and gradual weaning may be clinically challenging. Therefore, supportive dietary or microbiota-targeted strategies that may facilitate maintenance management and discontinuation of macrogol are of clinical interest.
Bifidobacterium longum W11 is a probiotic strain with potential effects on intestinal function and motility, while Colopectin contains prebiotic and fiber-related components that may help support bowel regularity. The combination is being investigated as a co-supplementation strategy in children with functional constipation during the maintenance phase of treatment.
This study is a randomized, double-blind, placebo-controlled, parallel-group trial in children aged 2 to 6 years with functional constipation who have been receiving maintenance-dose macrogol for at least 3 months and are candidates for treatment weaning. A total of 100 participants will be randomized in a 1:1 ratio to receive either Bifidobacterium longum W11 (Bowell®) plus Colopectin (Colopectin®) or placebo, administered once daily between meals in the afternoon for 4 weeks. After the treatment period, supplementation will be discontinued and participants will be monitored for an additional 4 weeks.
Clinical assessments will be performed at baseline (T0), at Week 4 (T1), and at Week 8 (T2). The primary endpoint is persistence of constipation, defined as 2 or fewer bowel movements per week, after discontinuation of macrogol therapy. Secondary endpoints include changes in stool consistency assessed using the Bristol Stool Scale, presence or absence of distress during evacuation, number of soiling episodes, and treatment compliance.
- Conditions
- Functional Constipation
- Being tested
- Bifidobacterium longum W11 (Bowell®) + Colopectin (Colopectin®), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium longum W11 (Bowell®) + Colopectin (Colopectin®)Dietary supplement
Combination of probiotic (Bifidobacterium longum W11) and prebiotic components (Colopectin) administered in sachet form once daily between meals in the afternoon.
PlaceboOther
Placebo composed of corn starch, matched in appearance and administration schedule to the active intervention.
| Study group | Role | What they receive |
|---|---|---|
| Bifidobacterium longum W11 (Bowell®) + Colopectin + (Colopectin®) | Experimental | Participants will receive co-supplementation with Bifidobacterium longum W11 (Bowell®) and Colopectin (Colopectin®) administered once daily between meals in the afternoon for 4 weeks, followed by 4 weeks of follow-up after treatment discontinuation. Receives: Dietary Supplement: Bifidobacterium longum W11 (Bowell®) + Colopectin (Colopectin®) |
| Placebo | Placebo comparator | Participants will receive placebo (corn starch) formulated in sachets, administered once daily between meals in the afternoon for 4 weeks, followed by 4 weeks of follow-up after treatment discontinuation. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence of Constipation After Discontinuation of Macrogol Therapy
Persistence of constipation defined as 2 or fewer bowel movements per week after discontinuation of macrogol therapy.
Measured: Week 8
Secondary outcomes (4)
Change in Stool Consistency (Bristol Stool Scale)
Change in stool consistency assessed using the Bristol Stool Scale between baseline (T0), Week 4 (T1), and Week 8 (T2).
Measured: Baseline, Week 4, and Week 8
Presence of Distress During Evacuation (Caregiver-Reported Assessment)
Assessment of presence or absence of distress during defecation based on caregiver or parent report recorded during clinical evaluation.
Measured: Baseline, Week 4, and Week 8
Number of Soiling Episodes
Number of episodes of fecal soiling during the study period.
Measured: Baseline, Week 4, and Week 8
Participant Compliance With Assigned Intervention (Caregiver-Reported Administration)
Assessment of participant compliance with the assigned intervention based on caregiver or parent report of administration of the study product during the treatment period.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion19 Apr 2027 (estimated)
- Study completion17 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional 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
- Model description
- Participants will be randomized in a 1:1 ratio to receive either co-supplementation with Bifidobacterium longum W11 and Colopectin or placebo in a parallel-group design. Treatment will be administered once daily for 4 weeks, followed by 4 weeks of follow-up after discontinuation.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi dell'Insubria
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536698
- Sponsor's protocol ID
- CET no. 5174/26/25.03.2026
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Co-supplementation With Bifidobacterium Longum W11 and Colopectin in the Maintenance Therapy of Children With Functional Constipation: A Randomized Double-Blind Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07536698
- Acronym / sponsor ID
- CET no. 5174/26/25.03.2026
- Conditions
- Functional Constipation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- Università degli Studi dell'Insubria
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 19 Apr 2027 (estimated)
- Study completion
- 17 May 2027 (estimated)
- First posted
- 17 Apr 2026 (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.
Functional constipation is a common condition in children and often requires prolonged maintenance treatment with macrogol. This randomized, double-blind, placebo-controlled trial will evaluate whether co-supplementation with Bifidobacterium longum W11 and Colopectin can support maintenance therapy in children with functional constipation who are receiving macrogol and are candidates for weaning. Participants aged 2 to 6 years will be randomized to receive either the active supplementation or placebo once daily for 4 weeks, followed by 4 weeks of follow-up after treatment discontinuation. The study will assess persistence of constipation after macrogol discontinuation, as well as stool consistency, distress during evacuation, soiling episodes, and treatment compliance.
Detailed description
Functional constipation is one of the most common gastrointestinal disorders in childhood and is frequently associated with painful or infrequent defecation, stool retention, and reduced quality of life. In many children, maintenance treatment with macrogol is required for prolonged periods, and gradual weaning may be clinically challenging. Therefore, supportive dietary or microbiota-targeted strategies that may facilitate maintenance management and discontinuation of macrogol are of clinical interest.
Bifidobacterium longum W11 is a probiotic strain with potential effects on intestinal function and motility, while Colopectin contains prebiotic and fiber-related components that may help support bowel regularity. The combination is being investigated as a co-supplementation strategy in children with functional constipation during the maintenance phase of treatment.
This study is a randomized, double-blind, placebo-controlled, parallel-group trial in children aged 2 to 6 years with functional constipation who have been receiving maintenance-dose macrogol for at least 3 months and are candidates for treatment weaning. A total of 100 participants will be randomized in a 1:1 ratio to receive either Bifidobacterium longum W11 (Bowell®) plus Colopectin (Colopectin®) or placebo, administered once daily between meals in the afternoon for 4 weeks. After the treatment period, supplementation will be discontinued and participants will be monitored for an additional 4 weeks.
Clinical assessments will be performed at baseline (T0), at Week 4 (T1), and at Week 8 (T2). The primary endpoint is persistence of constipation, defined as 2 or fewer bowel movements per week, after discontinuation of macrogol therapy. Secondary endpoints include changes in stool consistency assessed using the Bristol Stool Scale, presence or absence of distress during evacuation, number of soiling episodes, and treatment compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either co-supplementation with Bifidobacterium longum W11 and Colopectin or placebo in a parallel-group design. Treatment will be administered once daily for 4 weeks, followed by 4 weeks of follow-up after discontinuation.
| Arm | Type | Receives |
|---|---|---|
| Bifidobacterium longum W11 (Bowell®) + Colopectin + (Colopectin®) | Experimental | Dietary Supplement: Bifidobacterium longum W11 (Bowell®) + Colopectin (Colopectin®)Participants will receive co-supplementation with Bifidobacterium longum W11 (Bowell®) and Colopectin (Colopectin®) administered once daily between meals in the afternoon for 4 weeks, followed by 4 weeks of follow-up after treatment discontinuation. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive placebo (corn starch) formulated in sachets, administered once daily between meals in the afternoon for 4 weeks, followed by 4 weeks of follow-up after treatment discontinuation. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 2 to 6 years
- Diagnosis of functional constipation
- Receiving maintenance therapy with macrogol for at least 3 months
- Candidates for weaning from macrogol therapy
Key exclusion criteria (5 listed)
- Children with intestinal meteorism or flatulence
- Children diagnosed with organic constipation
- History of previous abdominal surgery
- Children with frailty or disabilities
- Presence of other organ diseases or syndromes
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 |
|---|---|---|
| Bifidobacterium longum W11 (Bowell®) + Colopectin (Colopectin®)Combination of probiotic (Bifidobacterium longum W11) and prebiotic components (Colopectin) administered in sachet form once daily between meals in the afternoon. | Dietary supplement | Bifidobacterium longum W11 (Bowell®) + Colopectin + (Colopectin®) |
| PlaceboPlacebo composed of corn starch, matched in appearance and administration schedule to the active intervention. | Other | Placebo |
Primary outcome
Persistence of Constipation After Discontinuation of Macrogol Therapy
Time frame: Week 8
Persistence of constipation defined as 2 or fewer bowel movements per week after discontinuation of macrogol therapy.
4 secondary outcomes
Change in Stool Consistency (Bristol Stool Scale)
Time frame: Baseline, Week 4, and Week 8
Presence of Distress During Evacuation (Caregiver-Reported Assessment)
Time frame: Baseline, Week 4, and Week 8
Number of Soiling Episodes
Time frame: Baseline, Week 4, and Week 8
Participant Compliance With Assigned Intervention (Caregiver-Reported Administration)
Time frame: Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
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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.
Dr Amjad Khan, DPhil contact
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium longum W11 (Bowell®) + Colopectin (Colopectin®) in people with Functional Constipation, run by Liaquat University of Medical & Health Sciences.
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 5 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: opening soon, as of the sponsor's last update on 17 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Valitutti, MD, PhD (+39 392 232 2182, Francesco.valitutti@unipg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistence of Constipation After Discontinuation of Macrogol Therapy (time frame: Week 8). 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 17 Apr 2026.