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

Study Overview
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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.

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

Conditions
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Bowel Dysfunction, Helicobacter Pylori Infection

Intervention / Treatment
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* Dietary Supplement: Probiotics product


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Dietary Supplement: Probiotics product<br>* 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.<br>|
| Experimental: Probiotics product<br> | Dietary Supplement: Probiotics product<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |