| Trial name or title |
Study for investigating the effects of a probiotic on diarrhea caused by chemotherapy in patients with gastric, colon, and rectum cancer |
| Methods |
Allocation: randomised controlled trial
Control: placebo
Study endpoint classification: efficacy study
Intervention model: parallel
Number of arms: 2
Masking: double‐blind (masked roles: subject, investigator, outcomes assessor)
Primary purpose: prevention
Study phase: 3 |
| Participants |
Gastric or colorectal cancer, for which treatment with 5‐fluorouracil and 1 further chemotherapeutic remedy (irinotecan or a platinum‐based chemotherapeutic remedy) is planned
Inclusion criteria:
Male or female adults; patients with gastric or colorectal cancer (stage III or IV), for which treatment with 5‐fluorouracil and 1 further chemotherapeutical remedy (irinotecan or a platinum‐based chemotherapeutical remedy) is planned Addition of bevacizumab antibody is allowed as well; life expectancy of at least the trial duration First administration of the product under investigation must take place 72 hours before or after the beginning of the chemotherapeutical treatment, ideally at the same time Inclusion into the study is possible only at the beginning of the first chemotherapeutic cycle Fertile female patients (aged 49 years or younger, last menstruation occurred within last 2 years), surgically sterilised or using the same highly effective method of contraception for ≥ 3 months Willingness to refrain from other probiotics or probiotic yogurts; a systematic change in eating behaviour should not be planned Sufficient knowledge of German language and sufficient psychological state to complete questionnaires and assessment scales Informed written consent
Exclusion criteria:
Participation in other clinical trials (currently or within past 30 days) Intolerance against ingredients of the product under investigation; pregnancy or lactation Not able to orally consume the product under investigation Antidiarrhoeal therapy with antibiotics Alcohol or drug abuse within past 6 months Any health condition (including abnormal blood parameters) that prevents patient from taking part in the study according to the opinion of the investigator
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| Interventions |
Intervention group: Mutaflor Suspension. Oral suspension
Placebo group: oral suspension |
| Outcomes |
Primary outcome measures:
Secondary outcome measures:
Quality of life (according to SF‐12 and FACIT‐D) Stool consistency according to the Bristol Stool Scale Anthropometry (body mass index (BMI)) Bioelectrical impedance analysis (BIA) Blood parameters (C‐reactive protein, haematocrit) Stool parameters (α1‐antitrypsin, calprotectin)
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| Starting date |
ClinicalTrials.gov Identifier: EUCTR2015‐000868‐34‐DE
Study start date: 9 April 2015 |
| Contact information |
Contact: Clinical Trials Information
info@zkes‐gmbh.de |
| Notes |
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