Clinical Pilot Trial on the Effect of a Probiotic Fermented Drink on Antibiotic-associated Diarrhea (AAD)

NCT ID: NCT02746198

Last Updated: 2021-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-22
• Study Completion Date: 2017-04-26

Brief Summary

The aim of the study is to estimate the effect of a probiotic dairy drink on occurrence and duration of AAD and gastrointestinal symptoms during Helicobacter pylori (Hp) eradication therapy and during 4 weeks thereafter and calculating the sample size for a confirmatory study.

Detailed Description

Helicobacter p. positive subjects aged ≥18 years with an indication for Helicobacter pylori (Hp) eradication recommended by a gastroenterologist should be included in the study. Subjects should be willing to consume 2 servings of the study product per day for 6 weeks, and to undergo an Hp eradication therapy for 14 days starting with the consumption period.

Conditions

Antibiotic-associated Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Verum

2 bottles (á 65ml) of a probiotic dairy drink consumed daily for 6 weeks

Group Type: EXPERIMENTAL

probiotic dairy drink

Intervention Type: OTHER

Placebo

2 bottles (á 65ml) of a dairy drink containing chemically acidified milk without bacterial strains consumed daily for 6 weeks

Group Type: PLACEBO_COMPARATOR

acidified milk

Intervention Type: OTHER

Interventions

probiotic dairy drink

Intervention Type: OTHER

acidified milk

Intervention Type: OTHER

Other Intervention Names

verum; placebo

Eligibility Criteria

Inclusion Criteria

• Individuals, both genders, aged ≥ 18 y
• Helicobacter p. infected individuals, to which eradication therapy has been recommended by gastroenterologists
• Willingness to undergo the Helicobacter p. eradication therapy
• Willingness to abstain from food and supplements containing probiotics, prebiotics and fermented products except the study product
• Written informed consent

Exclusion Criteria

• Subjects currently enrolled in another interventional trial
• subjects having finished another interventional trial within the last 4 weeks before inclusion
• incapacity to comply with the study protocol
• allergy or hypersensitivity to any component of the test product (allergy against milk protein)
• allergy or hypersensitivity to any component of the eradication therapy (e.g. penicillin allergy)
• acute GIT infections
• chronic inflammatory bowel diseases (IBD)
• irritable bowel syndrome (IBS)
• any episode of diarrhea according to WHO criteria during the last 4 weeks before inclusion
• history of lactose intolerance
• severe chronic disease (cancer, malabsorption, malnutrition, severe chronic inflammatory diseases (except chronic gastritis), renal, hepatic or cardiac diseases, artificial cardiac valve, COPD, respiratory insufficiency)
• history of active or persistent hepatitis B and C
• known congenital, acquired or iatrogenic immunodeficiency (e.g. HIV, chemotherapy, immunosuppression)
• systemic treatment with antibiotics during the last 4 weeks before inclusion
• systemic treatment likely influencing absorption, metabolism and excretion of food ingredients (metoclopramide, laxatives, body weight management and/or medication etc.)
• systemic treatment likely interfering or influencing effectiveness of the eradication drugs used e.g. ergotamine, statins, clopidogrel
• regular medical treatment including OTC, which may have impact on the study aims (e.g. probiotics, antibiotic drugs, laxatives etc.)
• severe neurological, cognitive or psychiatric diseases
• surgery or intervention requiring general anaesthesia within 2 months before the study
• vegan
• eating disorders (e.g. anorexia, bulimia)
• present alcohol and drug abuse
• pregnancy or lactation
• legal incapacity
• blood parameters:

• Hb < 12 g/dL
• liver transaminases (ALT, AST) > 2-fold increased
• serum creatinine out of the normal range
• subjects who are scheduled to undergo hospitalization during the study period

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yakult Honsha Co., LTD

INDUSTRY

Sponsor Role: collaborator

Clinical Research Center Kiel GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chiyuki Kajita

Role: STUDY_CHAIR

Yakult Europe BV

Locations

CRC Clinical Research Center Kiel

Kiel, Schleswig-Holstein, Germany

Countries

Germany

Other Identifiers

14DE-KIEL-HPAAD1

Identifier Type: -

Identifier Source: org_study_id