NCT07360535

Brief 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. 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2020

Longer than P75 for phase_2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2020

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

March 31, 2026

Status Verified

January 1, 2026

Enrollment Period

5.7 years

First QC Date

January 13, 2026

Last Update Submit

March 26, 2026

Conditions

Functional Constipation in Children

Keywords

Bifidobacterium longum subsp. longum Dipro-Xfunctional constipationinfantstoddlersprobiotic

Outcome Measures

Primary Outcomes (3)

  • 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).

    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

    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

    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

    Day-0, day-28

Study Arms (3)

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)

Dietary Supplement: Probiotic

Lactulose

ACTIVE COMPARATOR

Lactulose liquid (each 1ml contains 0.667g lactulose) 5ml/time, once a day

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

Dietary Supplement: probiotic + lactulose

Interventions

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)

Probiotic
Lactulose Oral Liquid ProductDIETARY_SUPPLEMENT

Lactulose liquid (each 1ml contains 0.667g lactulose) 5ml/time, once a day

Lactulose
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

Probiotic+Lactulose

Eligibility Criteria

Age0 Years - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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;
  • Term infants, gestational age from 37 to 42 weeks;
  • Birth weight between 2500 - 4000g;
  • years old;
  • Parents voluntarily defer major changes in infant feeding practices;
  • Parents are willing and able to fill in diaries and questionnaires

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Universiti Sains Malaysia

Pulau Pinang, Malaysia

Location

MeSH Terms

Interventions

ProbioticsLactulose

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesDisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Yi Feng, MD.

    Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 22, 2026

Study Start

June 10, 2020

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

March 31, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)CN(1)