NCT06637397

Brief Summary

To investigate the clinical effects of probiotics in relieving chronic constipation in adults, and evaluate the improvement of symptoms in patients with constipation as well as their impacts on gastrointestinal function, immunity, and gut microbiota.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

May 30, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

May 27, 2024

Last Update Submit

October 9, 2024

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

  • Assessing the Improvement of Chronic Constipation Symptoms Following Probiotic Intervention.

    Constipation symptoms are measured using Bristol Stool Form Scale (BSFS).

    8 weeks

Study Arms (2)

Probiotic Group

EXPERIMENTAL

Participants receive one sachet per day containing probiotic BC99 and maltodextrin (Week 0 to Week8).

Dietary Supplement: Probiotic

Placebo Group

PLACEBO COMPARATOR

Participants receive one sachet per day containing maltodextrin only, serving as the placebo(Week 0 to Week8).

Dietary Supplement: Placebo

Interventions

ProbioticDIETARY_SUPPLEMENT

During the intervention, participants can consume BC99 daily and any adverse reactions were noted. Stool and serum samples were collected for analysis of 16S rRNA and serum inflammatory markers. Changes in intestinal flora and inflammatory factors before and after supplementation were assessed.

Probiotic Group
PlaceboDIETARY_SUPPLEMENT

During the intervention, participants can consume maltodextrin daily and any adverse reactions were noted. Stool and serum samples were collected for analysis of 16S rRNA and serum inflammatory markers. Changes in intestinal flora and inflammatory factors before and after supplementation were assessed.

Placebo Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chinese adults who meet the diagnostic criteria of Rome III, aged between 18 and 70;
  • Patients with chronic constipation (disease duration exceeding 6 months, with fewer than 3 bowel movements per week and/or Bristol stool form scale types 1 and 2);
  • Able to complete the study according to the requirements of the experimental protocol;
  • Patients who have signed the informed consent form;
  • Research participants (including male participants) who do not have fertility plans from 14 days before screening to 6 months after the end of the trial and are willing to take effective contraceptive measures voluntarily.

You may not qualify if:

  • Individuals who have taken items with similar functions to the tested product within a short period of time, which may affect the judgment of the results;
  • Patients who have changed their diet during the study period;
  • Patients with severe allergies and immune deficiencies;
  • Female patients who are pregnant, breastfeeding, or have plans to become pregnant;
  • Patients with severe diseases in vital organs such as cardiovascular, lung, liver, and kidney, as well as severe metabolic diseases such as diabetes, thyroid disease, malignant tumors, and severe immune system diseases;
  • Individuals who have used antibiotics within the past two weeks;
  • Individuals with severe psychological or mental illnesses;
  • Participants who have not consumed the tested samples as required or failed to follow up on time, resulting in an inability to determine the effectiveness;
  • Other research participants deemed unsuitable for participation by the researchers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Henan University of Science and Technology

Luoyang, Henan, 471000, China

RECRUITING

The School of Food and Bioengineering, Henan University of Science and Technolog

Luoyang, Henan, 471000, China

RECRUITING

MeSH Terms

Conditions

Constipation

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Ying Wu

CONTACT

18639283502wuying2000@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2024

First Posted

October 15, 2024

Study Start

May 30, 2024

Primary Completion

August 30, 2024

Study Completion

November 15, 2024

Last Updated

October 15, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)