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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04319991
Other study ID # FYH-IRB-108-07-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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