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

NCT04319991 | Unknown

• 1 other identifier: FYH-IRB-108-07-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Dysfunction; Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Probiotics product

Probiotics product

EXPERIMENTAL

Dietary Supplement: Probiotics product

Interventions

Probiotics product 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.

Placebo; Probiotics product

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fooyin University: lead

Study Sites (1)

Fooyin University Hospital

Pingtung City, 92847, Taiwan

RECRUITING

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Lin Ching Chiang, doctor

CONTACT

886-8-832-3146; x6053@ms25.hinet.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 24, 2020
• Study Start: November 15, 2019
• Primary Completion: June 1, 2021
• Study Completion: November 1, 2021
• Last Updated: February 3, 2021

Record last verified: 2021-02

Locations

TW (1)