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

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.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection; Bowel Dysfunction
• Intervention / Treatment: Dietary supplement: Probiotics product

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lin Ching Chiang, doctor; Phone Number: 3281 886-8-832-3146; Email: x6053@ms25.hinet.net

Study Locations

• Taiwan
  • Pingtung, Taiwan, 92847
    • Recruiting
    • Fooyin University Hospital
    • Contact: Lin Ching Chiang, doctor; Phone Number: 3281 886-832-3146; Email: x6053@ms25.hinet.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The degree of microbiota correction or improvement by specific probiotic strain(s)	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.	Changes from Baseline Fecal Microbiota at 4 weeks
Questionnaire to assess the severity and frequency of symptoms was reported	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.	Changes from Baseline GSRS at 4 weeks

Collaborators and Investigators

• Sponsor: Fooyin University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Intestinal Diseases; Helicobacter Infections
• Other Study ID Numbers: FYH-IRB-108-07-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No