MedTrace Logo

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

NCT07360535 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-04-07

No results posted yet for this study

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.

Conditions

  • Functional Constipation in Children

Interventions

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)

DIETARY_SUPPLEMENT

Lactulose Oral Liquid Product

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

Sponsors & Collaborators

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Min-Tze LIONG

    lead OTHER

Principal Investigators

  • Yi Feng, MD. · Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-10
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • China
  • Malaysia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07360535 on ClinicalTrials.gov