The Clinical Evaluation of Probiotics Product in Patients With Various Functional Bowel Disorders and Helicobacter Pylori Infection

• Sponsor: Fooyin University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04319991
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23.6
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

People nowadays tend to have irregular diet and routine due to the stress at work. This condition may cause intestinal microflora imbalance, and in the long term may lead to constipation, diarrhea, gastroenteritis, gastric ulcer and other gastrointestinal diseases. Helicobacter pylori infection, which can trigger gastrointestinal inflammation and ulcer, is commonly treated by antibiotics. This treatment, however, can reduce the diversity of the intestinal microflora, causing diarrhea, flatulence and nausea. Clinical trials showed that probiotics and prebiotics supplementation could regulate gastrointestinal function, including alleviating constipation, ameliorating antibiotic-associated diarrhea and flatulence, enhancing the effect of H. pylori treatment, and restoring the balance of intestinal microflora. This Probiotics product is a supplement containing several types of probiotics and prebiotics which has been marketed for years. This project aims to observe the effectiveness of Probiotics product consumption by H. pylori-infected patients in relieving the gastrointestinal symptoms and restoring their intestinal microflora.

Condition or Disease	Intervention/Treatment	Phase
Bowel Dysfunction; Helicobacter Pylori Infection	Dietary Supplement: Probiotics product	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: The Clinical Evaluation of Probiotics Product in Patients With Various Functional Bowel Disorders and Helicobacter Pylori Infection
• Actual Study Start Date: Nov 15, 2019
• Anticipated Primary Completion Date: Jun 1, 2021
• Anticipated Study Completion Date: Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Dietary Supplement: Probiotics product; This Probiotics product is a supplement containing several types of probiotics and prebiotics which has been marketed for years in Taiwan. Each sachet contains 3 grams granule. Take 1 sticks 3 times per day with or without water before meals.
Experimental: Probiotics product	Dietary Supplement: Probiotics product; This Probiotics product is a supplement containing several types of probiotics and prebiotics which has been marketed for years in Taiwan. Each sachet contains 3 grams granule. Take 1 sticks 3 times per day with or without water before meals.

Outcome Measures

Primary Outcome Measures

1. The degree of microbiota correction or improvement by specific probiotic strain(s) [Changes from Baseline Fecal Microbiota at 4 weeks]

   16S ribosomal RNA (rRNA) sequencing is a common amplicon sequencing methods used to identify and compare bacteria present within a given sample. 16S rRNA gene sequencing is a well-established method for comparing sample phylogeny and taxonomy from complex microbiomes.

2. Questionnaire to assess the severity and frequency of symptoms was reported [Changes from Baseline GSRS at 4 weeks]

   The Gastrointestinal Symptom Rating Scale (GSRS) is a disease-specific questionnaire of 15 items to assess the severity and frequency of symptoms was reported; GSRS uses a 7-point Likert scale ranging from 1 = no problem to 7 = a very severe problem.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria (PART I : For patients with bowel disorders):

• Constipation : Must include 2 or more of the following:

• straining during at least 25% of defecations

• lumpy or hard stools in at least 25% of defecations

• sensation of incomplete evacuation for at least 25% of defecations

• sensation of anorectal obstruction/blockage for at least 25% of defecations

• manual maneuvers to facilitate at least 25% of defecations

• fewer than 3 defecations per week

• Diarrhea :

• the passage of 3 or more loose or liquid stools per day and lasting more than 1 week, or more frequently than is normal for the individual.

Inclusion Criteria (PART II : For patients with Helicobacter pylori infection):

• Campylobacter-like organism test (CLO test) positive

Exclusion Criteria (PART I & II)

• prior upper digestive tract surgery

• a history of cancer

• lactose intolerance

• allergy to penicillin

• prior antibiotics therapy in the last month

• prior probiotics supplement more than once a week in the last three weeks

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fooyin University Hospital	Pingtung		Taiwan	92847

Sponsors and Collaborators

• Fooyin University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ching-Chiang, Lin, professor, Fooyin University
• ClinicalTrials.gov Identifier: NCT04319991
• Other Study ID Numbers: FYH-IRB-108-07-01
• First Posted: Mar 24, 2020
• Last Update Posted: Feb 3, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Helicobacter Infections; Intestinal Diseases

Study Results

No Results Posted as of Feb 3, 2021