Effect of Probiotic on Gut Microbiota in Young Children With Functional Constipation

March 31, 2026 updated by: Min-Tze LIONG
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Malaysia
      • Pulau Pinang, Malaysia
        • Universiti Sains Malaysia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • According to the diagnostic criteria of Rome IV, the following symptoms include at least 2 and last for at least 1 month:

    1. Defecation <= 2 times per week;
    2. have a history of fecal retention;
    3. There is a history of pain or difficulty in defecation;
    4. There is a history of expelling large pieces of feces;
    5. 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;
  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Probiotic
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)
Dietary supplement: Probiotic
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)
Active Comparator: Lactulose
Lactulose liquid (each 1ml contains 0.667g lactulose) 5ml/time, once a day
Dietary supplement: Lactulose Oral Liquid Product
Lactulose liquid (each 1ml contains 0.667g lactulose) 5ml/time, once a day
Active Comparator: Probiotic+Lactulose
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
Dietary supplement: probiotic + lactulose
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
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
Time Frame: Day-0, day-28
Differences in bowel movement frequency in young children upon administration of probiotic, lactulose or their combinations
Day-0, day-28
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
Day-0, day-14, day-28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Differences in microbiota profiles in fecal sample of young children upon administration probiotic, lactulose or their combinations
Day-0, day-28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Min-Tze LIONG

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yi Feng, MD., Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XHEC-C-2018-027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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