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

Fooyin University

Status: Unknown

Conditions: Helicobacter Pylori Infection; Bowel Dysfunction

Treatments: Dietary Supplement: Probiotics product

Study type: Interventional

Funder types: Other

Identifiers

NCT04319991

FYH-IRB-108-07-01

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Probiotics product

Probiotics product

Experimental group

Treatment:

Dietary Supplement: Probiotics product