Gut Health Study - effectiveness of probiotics (OMNI-BiOTiC 10) combined with individual nutritional counselling with focus on prebiotic nutrition compared to solely individual nutritional counselling to improve gastrointestinal symptoms of bowel cancer survivors - a prospective double-blind randomized placebo-controlled trial

Not Applicable

Recruiting

Conditions: K59.9
Functional intestinal disorder, unspecified

Registration Number: DRKS00025802

Lead Sponsor: niversitäres Cancer Center Hamburg (UCCH) - Hubertus Wald Tumorzentrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

patients after bowel cancer disease with gastrointestinal symptoms
- 3 months to 5 years after cessation of cancer treatment
- expectancy > 6 months
- full-aged
- written informed consent

Exclusion Criteria

- active infections > level 2 NCI-CTCAE V5.0
- severe systemic disease such as uncontrolled hypertension, heart failure or uncorntolled hyperglycaemia
- course of antibiotics in the past 8 weeks
- uncontrolled diabetes type 1 or 2
- immunosuppressive therapy, slow-healing wounds, ulcers, bone fractures
- pregnant women or those wishing to become pregnant as well as patients who do not apply contraceptive methods
- all conditions that could possibly compromise study outcome or patients safety
- all familial, psychologial or socialogical conditions that do not comply with the protocol
- participation in a study with an investigational product in the last 15 days before inclusion
- incarcerated patients
- enteral supplementation or parenteral nutrition or sip feeds (when covering over 50% of energy demand) after therapy of tumor cachexia
- presence of intestinal stenosis

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
gastrointestinal symptoms (difference 12 weeks after baseline) measured by EORTC-C30 /C29)

Secondary Outcome Measures

Name	Time	Method
- microbiota determination (through 16S rRNA gene analysis) of the stool and a coloscopically extracted sample from the aftercare coloscopy<br>- Nutritional behaviour and assessment of the fibre intake (24h-recall)<br>- stool frequency and stool consistency + further gastrointextinal symptoms through anamnesis and bristol stool scale<br>- biochemical parameter: liver and kidney function readings, CRP, cytokine (e.g. Interleukin-6 and TNF-alpha)<br>- recurrence free survival and overall survival <br>- assessment of quality of life and disease related symptoms through EORTC-C30/C29<br>- adherence of probiotics intake <br>- weight