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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04319991
• Other study ID #: FYH-IRB-108-07-01
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: November 2021

Study information

• Verified date: February 2021
• Source: Fooyin University
• Contact: Lin Ching Chiang, doctor
• Phone: 886-8-832-3146
• Email: x6053[@]ms25.hinet.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bowel Dysfunction
• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection
• Intestinal Diseases

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Fooyin University Hospital	Pingtung

Sponsors (1)

Lead Sponsor	Collaborator
Fooyin University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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