Effect of Probiotic Formula on Reducing the Risk for Antibiotic-associated Diarrhoea

NCT01596829 | Terminated Phase 2

• 2 other identifiers: AAD-EU20122012-001542-18
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

Antibiotic treatment disturbs the balance of the intestinal microbiota and predisposes to antibiotic associated diarrhea. Previous studies have shown that the risk of developing diarrhea during a course of antibiotics may be reduced by simultaneous consumption of probiotics. The aim of the present study is to assess the effect of a probiotic formula containing four strains on reducing the risk of antibiotic associated diarrhea.

Conditions

Antibiotic-associated Diarrhoea

Keywords

antibiotic; probiotic; antibiotic-associated diarrhoea; faecal microbiota

Outcome Measures

Primary Outcomes (1)

• Incidence of AAD

  Incidence of diarrhoea defined as three or more loose or watery stools per a 24 h period.

  Up to 21 days

Secondary Outcomes (3)

• Duration of diarrhoea

  Up to 21 days

• Fecal microbiota

  Up to 21 days

• Safety profile

  Up to 21 days

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Probiotic consumption during and after course of antibiotic

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Placebo consumed during and after course of antibiotic

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Probiotic formula, 10 billion CFU in total once a day for up to 3 weeks

Also known as: Howaru Restore

Probiotic

Placebo DIETARY_SUPPLEMENT

A capsule with microcrystalline cellulose matching the appearance and taste of the active comparator

Also known as: Microcrystalline cellulose as placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged 18-65 years.
• Patients will be initiating antibiotic therapy.
• The antibiotic therapy consists of one of the following: broad spectrum penicillins, cephalosporins, doxycycline, clarithromycin, ciprofloxacin or isoxazolyl penicillin.
• The antibiotic therapy is expected to be 3 to 14 days in duration.
• Obtained his/her informed consent after verbal and written information.
• Have a high probability for compliance with and completion of the study.
• Patients having a telephone available.
• Body Mass Index between 19 and 30.

You may not qualify if:

• Participation in a clinical trial with an investigational product or drug within the 60 days prior to screening.
• Likeliness to be noncompliant with the protocol, or to be unsuitable to the study by the investigator for any reason.
• Pregnant or breastfeeding women; women planning to become pregnant during the study months.
• Presence of active diarrhea (3 or more loose or watery stools per 24 hour period).
• Daily consumption of probiotics, fermented milk and/or yogurt with probiotics.
• Known to have a previous reaction, including anaphylaxis, to any substance in composition of the study product (i.e. on-medicinal ingredients: Cellulose, hypromellose, magnesium stearate (vegetable source), ascorbic acid, Colloidal silicon dioxide).
• Presence of an active, non-controlled intestinal disease such as Crohn's Disease or ulcerative colitis.
• Regular use of proton pump inhibitors.
• Bowel surgery, artificial heart valve, history of rheumatic heart disease or infective endocarditis.
• A previous documented C. difficile infection \< 3 months prior to study initiation.
• Immunosuppressive therapy or any health condition causing immunosuppression (including haematological malignancies, AIDS).
• Ongoing or recent use of antibiotic therapy in the 3 months prior to the study product first administration.
• Planned administration of antibiotics other than broad spectrum penicillins, cephalosporins, doxycycline, ciprofloxacin or isoxazolyl penicillin for the treatment of an infection.
• History of drug or alcohol abuse.

Sponsors & Collaborators

• Danisco: lead

Study Sites (1)

Koskiklinikka

Tampere, Finland

Location

Related Publications (1)

• Forssten SD, Yeung N, Ouwehand AC. Fecal Recovery of Probiotics Administered as a Multi-Strain Formulation during Antibiotic Treatment. Biomedicines. 2020 Apr 9;8(4):83. doi: 10.3390/biomedicines8040083.

  PMID: 32283645 DERIVED

MeSH Terms

Interventions

Probiotics; microcrystalline cellulose

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Toivo Piippo, MD

  Koskiklinikka Tampereen Lääkärikeskus Oy

  PRINCIPAL INVESTIGATOR

• Anneli Tarpila, PhD

  Danisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 11, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 22, 2016

Record last verified: 2014-12

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)