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

Not Applicable

Completed

• Conditions: Antibiotic-associated Diarrhea
• Interventions: Other: probiotic dairy drink; Other: acidified milk

• Registration Number: NCT02746198
• Lead Sponsor: Clinical Research Center Kiel GmbH

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.

Study Timeline

• Study Start: 2016-01-22
• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-21
• Primary Completion: 2016-12-23
• Study Completion: 2017-04-26
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-05
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum	probiotic dairy drink	2 bottles (á 65ml) of a probiotic dairy drink consumed daily for 6 weeks
Placebo	acidified milk	2 bottles (á 65ml) of a dairy drink containing chemically acidified milk without bacterial strains consumed daily for 6 weeks

Primary Outcome Measures

Name	Time	Method
Occurrence of antibiotic-associated diarrhea (AAD)	6 weeks	Occurrence of antibiotic-associated diarrhea (AAD) (as defined by number of subjects with diarrhea within the intervention period of 6 weeks after starting antibiotic treatment; diarrhea is defined according WHO

Secondary Outcome Measures

Name	Time	Method
Cumulative sverity of antibiotic-associated diarrhea (AAD)	6 weeks	Sum of the values (obtained by transformation of Bristol stool form types) of all stools during days with diarrhea (transformation of Bristol scale types is defined: type 1 to 4 = 0; type 5 = 1; type 6 = 2 and type 7 = 3)
Gastrointestinal Symptom Rating Scale	6 weeks	Standardized questionnaire according Dimenäs et al.
Cumulated duration of antibiotic-associated diarrhea (AAD)	6 weeks	Number of days with diarrhea within the intervention period

Trial Locations

Locations (1)

CRC Clinical Research Center Kiel; 🇩🇪 Kiel, Schleswig-Holstein, Germany