Clinical trial NCT04319991: The Clinical Evaluation of Probiotics Product in Patients With Various Functional Bowel Disorders and Helicobacter Pylori Infection
Official title: The Clinical Evaluation of Probiotics Product in Patients With Various Functional Bowel Disorders and Helicobacter Pylori Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bowel Dysfunction
Helicobacter Pylori Infection
Lead sponsor: Fooyin University
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: The degree of microbiota correction or improvement by specific probiotic strain(s)
timeFrame: Changes from Baseline Fecal Microbiota at 4 weeks
measure: Questionnaire to assess the severity and frequency of symptoms was reported
timeFrame: Changes from Baseline GSRS at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pingtung
country: Taiwan
facility: Fooyin University Hospital
Study officials:
References: