NCT06122558

Brief Summary

This project aims to study the benefits of probiotic in modulating gut microbiota and treating functional constipation in patients aged 18-81.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2023

Geographic Reach
2 countries

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

October 27, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

October 27, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2025

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

October 27, 2023

Last Update Submit

November 2, 2023

Conditions

Constipation - Functional

Outcome Measures

Primary Outcomes (1)

  • Microbiota profiles of fecal samples in patients with functional constipation upon administration of probiotic or placebo

    Differences in microbiota abundance in fecal sample of patients with functional constipation upon administration of probiotic compared to placebo as assessed via DNA profiling of fecal samples upon Ilumina MiSeq sequencing

    8-weeks

Secondary Outcomes (5)

  • Constipation profiles of patients with functional constipation upon administration of probiotic or placebo

    8-weeks

  • Quality of life profiles of patients with functional constipation upon administration of probiotic or placebo

    8-weeks

  • Defecation profiles of patients with functional constipation upon administration of probiotic or placebo

    8-weeks

  • Defecation profiles of patients with functional constipation upon administration of probiotic or placebo

    8-weeks

  • Immunity profiles of patients with functional constipation upon administration of probiotic as assessed via blood samples

    8-weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

Probiotic Lactobacillus plantarum at 9 log CFU/day for 8 weeks

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Intervention consists of daily administration of 2g of maltodextrin, administered daily for 8-weeks)

Dietary Supplement: Placebo

Interventions

ProbioticDIETARY_SUPPLEMENT

Probiotic Lactobacillus plantarum at 9 log CFU/day for 8 weeks

Probiotic
PlaceboDIETARY_SUPPLEMENT

Intervention consists of daily administration of 2g of maltodextrin, administered daily for 8-weeks)

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Meet the diagnostic criteria for functional constipation in the Rome IV
  • Ruled out for IBS or secondary constipation

You may not qualify if:

  • Diagnosed with refractory constipation
  • Any other constipation caused by neurological diseases, metabolic diseases, obstructive diseases and drugs
  • Mental illness
  • Immunodeficiency diseases or used immunosuppressants, serious diseases of the heart, brain, kidney and other systems, malignant tumors, intestinal perforation, intestinal obstruction, intestinal bleeding
  • Currently using antibiotics or have a history of taking antibiotics in the past 4 weeks.
  • Participating in other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Deyang People's Hospital

Deyang, Sichuan, China

RECRUITING

School of Industrial Technology, Universiti Sains Malaysia

Pulau Pinang, Pulau Pinang, 11900, Malaysia

NOT YET RECRUITING

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Min Liong, PhD

    Universiti Sains Malaysia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Tze Liong, PhD

CONTACT

046532114mintze.liong@usm.my

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 8, 2023

Study Start

October 27, 2023

Primary Completion

October 26, 2025

Study Completion

October 26, 2025

Last Updated

November 8, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)CN(1)