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

Primary Purpose

Bowel Dysfunction, Helicobacter Pylori Infection

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Probiotics product
Sponsored by
Fooyin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bowel Dysfunction

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fooyin University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Probiotics product

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 6, 2020
Last Updated
February 1, 2021
Sponsor
Fooyin University
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1. Study Identification

Unique Protocol Identification Number
NCT04319991
Brief Title
The Clinical Evaluation of Probiotics Product in Patients With Various Functional Bowel Disorders and Helicobacter Pylori Infection
Official Title
The Clinical Evaluation of Probiotics Product in Patients With Various Functional Bowel Disorders and Helicobacter Pylori Infection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fooyin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel Dysfunction, Helicobacter Pylori Infection

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Probiotics product
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotics product
Intervention Description
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.
Primary Outcome Measure Information:
Title
The degree of microbiota correction or improvement by specific probiotic strain(s)
Description
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.
Time Frame
Changes from Baseline Fecal Microbiota at 4 weeks
Title
Questionnaire to assess the severity and frequency of symptoms was reported
Description
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.
Time Frame
Changes from Baseline GSRS at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Ching Chiang, doctor
Phone
886-8-832-3146
Ext
3281
Email
x6053@ms25.hinet.net
Facility Information:
Facility Name
Fooyin University Hospital
City
Pingtung
ZIP/Postal Code
92847
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Ching Chiang, doctor
Phone
886-832-3146
Ext
3281
Email
x6053@ms25.hinet.net

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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