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

NCT ID: NCT04319991

Last Updated: 2021-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-15

Study Completion Date

2021-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bowel Dysfunction Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Probiotics product

Intervention Type DIETARY_SUPPLEMENT

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.

Probiotics product

Group Type EXPERIMENTAL

Probiotics product

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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.


* Campylobacter-like organism test (CLO test) positive

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fooyin University

OTHER

Sponsor Role lead

Responsible Party

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Ching-Chiang, Lin

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fooyin University Hospital

Pingtung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Lin Ching Chiang, doctor

Role: CONTACT

886-8-832-3146 ext. 3281

Facility Contacts

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Lin Ching Chiang, doctor

Role: primary

886-832-3146 ext. 3281

Other Identifiers

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FYH-IRB-108-07-01

Identifier Type: -

Identifier Source: org_study_id

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