Functional Constipation in ChildrenPhase 2NCT07360535
Effect of Probiotic on Gut Microbiota in Young Children With Functional Constipation
A Phase 2 study testing Probiotic, Lactulose Oral Liquid Product and probiotic + lactulose in people with Functional Constipation in Children, run by Min-Tze LIONG at 2 sites in 2 countries.
Trial summary
This study was a 28-day, open-label, randomized controlled trial involving infants and toddlers diagnosed with functional constipation. Participants were randomized to receive either Bifidobacterium longum subsp. longum Dipro-X, lactulose, or a combination of both. Read more about this study
- Who is it for?
- Ages 0 to 3 years
- Conditions the study is for
- Functional Constipation in Children
- What is being tested?
- Probiotic, Lactulose Oral Liquid Product and probiotic + lactulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Jun 2020to 28 Feb 2026
- Phase
- Phase 2
- 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 0 to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- According to the diagnostic criteria of Rome IV, the following symptoms include at least 2 and last for at least 1 month:
- Defecation <= 2 times per week;
- have a history of fecal retention;
- There is a history of pain or difficulty in defecation;
- There is a history of expelling large pieces of feces;
- There is a large fecal mass in the rectum. At least 1 episode of incontinence per week after self-control of bowel movements; passing large pieces of stool that may clog the toilet;
Show all 11Show fewer
- Term infants, gestational age from 37 to 42 weeks;
- Birth weight between 2500 - 4000g;
- 0-3 years old;
- Parents voluntarily defer major changes in infant feeding practices;
- Parents are willing and able to fill in diaries and questionnaires
Who cannot join
- Chronic diseases or major medical problems;
- Gastrointestinal organic diseases;
- Growth retardation;
- The mother or child of the breastfeeding child used antibiotics within 4 weeks prior to enrollment;
- Infants (in formula and/or supplements) or their mothers used probiotics within 2 weeks before randomization and during the trial;
- Has participated in other clinical trials;
- Food allergies cause constipation (such as milk, eggs and other foods)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
China1 site
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
About this study
This study was a 28-day, open-label, randomized controlled trial involving infants and toddlers diagnosed with functional constipation. Participants were randomized to receive either Bifidobacterium longum subsp. longum Dipro-X, lactulose, or a combination of both. The primary clinical outcomes assessed were bowel movement frequency, stool consistency, and defecation difficulty. To investigate potential mechanisms, stool samples were collected pre- and post-intervention for metagenomics sequencing to analyze changes in gut microbiota composition and identify specific bacterial taxa associated with clinical improvements.
Read the detailed description
Functional constipation is a prevalent chronic gastrointestinal disorder with significant implications for pediatric health. Within the first year of life, many infants are affected, a figure that rises to over 10% annually. This condition not only diminishes the quality of life for infants and toddlers but also contributes to substantial healthcare costs. Early intervention is widely recognized as critical for improving treatment outcomes, underscoring the need for effective therapeutic strategies.
Growing evidence indicates that intestinal microbiota dysbiosis plays a key role in the pathogenesis of functional constipation. Studies have consistently reported reduced abundances of beneficial bacteria such as Lactobacillus and Bifidobacterium in affected individuals compared to healthy controls. These findings have spurred interest in microbiota-targeted interventions, particularly the use of Bifidobacterium, for managing constipation. Although current evidence-based guidelines do not uniformly recommend probiotics for infant constipation due to limited clinical data, their potential to restore microbial balance remains promising. Advances in genomic technologies have enabled more detailed investigations into strain-specific mechanisms, shifts in signature microorganisms, and associated symptomatic improvements, findings that may help bridge existing evidence gaps. While preclinical studies, such as those involving murine models, have shown that Bifidobacterium longum can alleviate constipation by enhancing intestinal barrier function, clinical evidence in pediatric populations remains scarce.
To address this, the present study was conducted as a randomized, open-label, three-arm controlled clinical trial. It aimed to evaluate the efficacy of Bifidobacterium longum subsp. longum Dipro-X, lactulose, and their combination in infants and toddlers with functional constipation. The study specifically assessed the intervention's effects on clinical symptoms, including defecation frequency and stool characteristics, and explored correlations between gut microbiota changes and symptom improvement. The results are intended to support the development of evidence-based, targeted microbial interventions for functional constipation in early childhood.
- Conditions
- Functional Constipation in Children
- Being tested
- Probiotic, Lactulose Oral Liquid Product, probiotic + lactulose
- Keywords
- Bifidobacterium longum subsp. longum Dipro-X, functional constipation, infants, toddlers, probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Daily 6-drops of Bifidobacterium longum subsp. longum Dipro-X in non-GMO corn starch as excipient, in medium-chain triglyceride oil (1× 10^9 CFU/day)
Lactulose Oral Liquid ProductDietary supplement
Lactulose liquid (each 1ml contains 0.667g lactulose) 5ml/time, once a day
probiotic + lactuloseDietary supplement
Daily 6-drops of Bifidobacterium longum subsp. longum Dipro-X in non-GMO corn starch as excipient, in medium-chain triglyceride oil (1× 10^9 CFU/day), plus Lactulose liquid (each 1ml contains 0.667g lactulose) 5ml/time, once a day
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Daily 6-drops of Bifidobacterium longum subsp. longum Dipro-X in non-GMO corn starch as excipient, in medium-chain triglyceride oil (1 × 10^9 CFU/day) Receives: Dietary Supplement: Probiotic |
| Lactulose | Active comparator | Lactulose liquid (each 1ml contains 0.667g lactulose) 5ml/time, once a day Receives: Dietary Supplement: Lactulose Oral Liquid Product |
| Probiotic+Lactulose | Active comparator | Daily 6-drops of Bifidobacterium longum subsp. longum Dipro-X in non-GMO corn starch as excipient, in medium-chain triglyceride oil (1 × 10^9 CFU/day), plus Lactulose liquid (each 1ml contains 0.667g lactulose) 5ml/time, once a day Receives: Dietary Supplement: probiotic + lactulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defecation difficulty in young children upon administration of probiotic, lactulose or their combinations as assessed via Visual Anologue Scale (VAS)
Differences in defecation difficulty in young children upon administration of probiotic, lactulose or their combinations, where higher scores indicate greater defecation difficulty (worse outcome).
Measured: Day-0, day-14, day-28
Bowel movement frequency in young children upon administration of probiotic, lactulose or their combinations as assessed via patients' diary
Differences in bowel movement frequency in young children upon administration of probiotic, lactulose or their combinations
Measured: Day-0, day-28
Bristol stool score in young children upon administration of probiotic, lactulose or their combinations as assessed via Bristol stool chart
Differences in Bristol stool score in young children upon administration of probiotic, lactulose or their combinations, where lower scores indicate constipation-like outcomes and higher scores indicate diarrea-like outcomes
Measured: Day-0, day-14, day-28
Secondary outcomes (1)
Microbiota profiles of fecal samples in young children upon administration of probiotic, lactulose or their combinations as assessed via metagenomics sequencing
Differences in microbiota profiles in fecal sample of young children upon administration probiotic, lactulose or their combinations
Measured: Day-0, day-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start10 Jun 2020
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Constipation in ChildrenStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Min-Tze LIONG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min-Tze LIONG, Universiti Sains Malaysia
- Investigators
- Yi Feng, MD., Principal investigator, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360535
- Sponsor's protocol ID
- XHEC-C-2018-027
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic on Gut Microbiota in Young Children With Functional Constipation
- ClinicalTrials.gov ID
- NCT07360535
- Acronym / sponsor ID
- XHEC-C-2018-027
- Conditions
- Functional Constipation in Children
- Keywords
- Bifidobacterium longum subsp. longum Dipro-X, functional constipation, infants, toddlers, probiotic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Min-Tze LIONGUniversity, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 22 Jan 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.
This study was a 28-day, open-label, randomized controlled trial involving infants and toddlers diagnosed with functional constipation. Participants were randomized to receive either Bifidobacterium longum subsp. longum Dipro-X, lactulose, or a combination of both. The primary clinical outcomes assessed were bowel movement frequency, stool consistency, and defecation difficulty. To investigate potential mechanisms, stool samples were collected pre- and post-intervention for metagenomics sequencing to analyze changes in gut microbiota composition and identify specific bacterial taxa associated with clinical improvements.
Detailed description
Functional constipation is a prevalent chronic gastrointestinal disorder with significant implications for pediatric health. Within the first year of life, many infants are affected, a figure that rises to over 10% annually. This condition not only diminishes the quality of life for infants and toddlers but also contributes to substantial healthcare costs. Early intervention is widely recognized as critical for improving treatment outcomes, underscoring the need for effective therapeutic strategies.
Growing evidence indicates that intestinal microbiota dysbiosis plays a key role in the pathogenesis of functional constipation. Studies have consistently reported reduced abundances of beneficial bacteria such as Lactobacillus and Bifidobacterium in affected individuals compared to healthy controls. These findings have spurred interest in microbiota-targeted interventions, particularly the use of Bifidobacterium, for managing constipation. Although current evidence-based guidelines do not uniformly recommend probiotics for infant constipation due to limited clinical data, their potential to restore microbial balance remains promising. Advances in genomic technologies have enabled more detailed investigations into strain-specific mechanisms, shifts in signature microorganisms, and associated symptomatic improvements, findings that may help bridge existing evidence gaps. While preclinical studies, such as those involving murine models, have shown that Bifidobacterium longum can alleviate constipation by enhancing intestinal barrier function, clinical evidence in pediatric populations remains scarce.
To address this, the present study was conducted as a randomized, open-label, three-arm controlled clinical trial. It aimed to evaluate the efficacy of Bifidobacterium longum subsp. longum Dipro-X, lactulose, and their combination in infants and toddlers with functional constipation. The study specifically assessed the intervention's effects on clinical symptoms, including defecation frequency and stool characteristics, and explored correlations between gut microbiota changes and symptom improvement. The results are intended to support the development of evidence-based, targeted microbial interventions for functional constipation in early childhood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticDaily 6-drops of Bifidobacterium longum subsp. longum Dipro-X in non-GMO corn starch as excipient, in medium-chain triglyceride oil (1 × 10^9 CFU/day) |
| Lactulose | Active comparator | Dietary Supplement: Lactulose Oral Liquid ProductLactulose liquid (each 1ml contains 0.667g lactulose) 5ml/time, once a day |
| Probiotic+Lactulose | Active comparator | Dietary Supplement: probiotic + lactuloseDaily 6-drops of Bifidobacterium longum subsp. longum Dipro-X in non-GMO corn starch as excipient, in medium-chain triglyceride oil (1 × 10^9 CFU/day), plus Lactulose liquid (each 1ml contains 0.667g lactulose) 5ml/time, once a day |
Who may qualify
- Ages
- 0 to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- According to the diagnostic criteria of Rome IV, the following symptoms include at least 2 and last for at least 1 month:
- Term infants, gestational age from 37 to 42 weeks;
- Birth weight between 2500 - 4000g;
- 0-3 years old;
- Parents voluntarily defer major changes in infant feeding practices;
Key exclusion criteria (7 listed)
- Chronic diseases or major medical problems;
- Gastrointestinal organic diseases;
- Growth retardation;
- The mother or child of the breastfeeding child used antibiotics within 4 weeks prior to enrollment;
- Infants (in formula and/or supplements) or their mothers used probiotics within 2 weeks before randomization and during the trial;
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 |
|---|---|---|
| ProbioticDaily 6-drops of Bifidobacterium longum subsp. longum Dipro-X in non-GMO corn starch as excipient, in medium-chain triglyceride oil (1× 10^9 CFU/day) | Dietary supplement | Probiotic |
| Lactulose Oral Liquid ProductLactulose liquid (each 1ml contains 0.667g lactulose) 5ml/time, once a day | Dietary supplement | Lactulose |
| probiotic + lactuloseDaily 6-drops of Bifidobacterium longum subsp. longum Dipro-X in non-GMO corn starch as excipient, in medium-chain triglyceride oil (1× 10^9 CFU/day), plus Lactulose liquid (each 1ml contains 0.667g lactulose) 5ml/time, once a day | Dietary supplement | Probiotic+Lactulose |
Primary outcome
Defecation difficulty in young children upon administration of probiotic, lactulose or their combinations as assessed via Visual Anologue Scale (VAS)
Time frame: Day-0, day-14, day-28
Differences in defecation difficulty in young children upon administration of probiotic, lactulose or their combinations, where higher scores indicate greater defecation difficulty (worse outcome).
Bowel movement frequency in young children upon administration of probiotic, lactulose or their combinations as assessed via patients' diary
Time frame: Day-0, day-28
Differences in bowel movement frequency in young children upon administration of probiotic, lactulose or their combinations
Bristol stool score in young children upon administration of probiotic, lactulose or their combinations as assessed via Bristol stool chart
Time frame: Day-0, day-14, day-28
Differences in Bristol stool score in young children upon administration of probiotic, lactulose or their combinations, where lower scores indicate constipation-like outcomes and higher scores indicate diarrea-like outcomes
1 secondary outcome
Microbiota profiles of fecal samples in young children upon administration of probiotic, lactulose or their combinations as assessed via metagenomics sequencing
Time frame: Day-0, day-28
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 7 Apr 2026.
- 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.
Yi Feng, MD. principal investigator
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic, Lactulose Oral Liquid Product and probiotic + lactulose in people with Functional Constipation in Children, run by Min-Tze LIONG at 2 sites in 2 countries.
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 11 inclusion and 7 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 7 Apr 2026. 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 China, Malaysia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Defecation difficulty in young children upon administration of probiotic, lactulose or their combinations as assessed via Visual Anologue Scale (VAS) (time frame: Day-0, day-14, day-28). The study lists 3 primary outcomes in all. 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 7 Apr 2026.