Clinical trial NCT02372201: Effects of Fasting and Hydro Colon Therapy Plus Probiotics on GI Microbiota in Intolerances and Irritable Bowel Syndrome
Official title: Effects of Fasting and Hydro Colon Therapy Plus Probiotics on Abundance and Diversity of GI Microbiota in Intolerances and Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Disease
Keywords: irritable bowel disease
microbiota
hydro colon therapy
food intolerance
Lead sponsor: University of Vienna
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Consequences of Colon Hydrotherapy plus probiotic intervention on composition of GI microbiota and well being are analysed in subjects claiming GI inconveniences due to Irritable Bowel Syndrome or food intolerances.

Detailed description: Study objectives: Analysis of consequences of Hydro Colon Therapy plus probiotic intervention on GI microbiota and well being.

Study group: 78 subjects, inclusion criteria: 20-50yrs; under consultation at doctors or nutritionists because of claimed food inconveniences or Irritable Bowel Syndrome. exclusion criteria: antibiotics treatment and specified complex diseases.

Intervention: Hydro colon therapy 2- 5 washes within 3 weeks. probiotic intervention after end of Hydro colon therapy for 6 weeks ( DUOLAC® bacterial strains per capsule: Lactobacillus plantarum, Streptococcus thermophiles, Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis, Bifidobacterium longum, and Bifidobacterium breve, fructooligosaccharides, 200 µg folic acid, 2.50 µg vitamin B12 and 55 µg selenium (all amounts corresponding to 100% of daily requirement). Control group: Vitamin B complex: 10µg cobalamin, 450µg folic acid, and 55 µg selenium.

Sample collection: standardized Feces collection, T1, before colon hydrotherapy, T2, immediately after colon hydrotherapy 2-5 washes of fasting ; T3, after six weeks of probiotic or Control intervention Analysis: standardizes food frequency questionnaire before and after intervention.

Feces analysis based on 16 S ribosomal DNA (rDNA) PCR DGGE and quantitative PCR (qPCR) and bioinformatic analysis.

Eligibility criteria: Inclusion Criteria:

* Subjects under consultation at doctors or nutritionists for Inflammatory Bowel Syndrome (IBD) of food intolerances

Exclusion Criteria:

* Pregnancy
* Antibiotic therapy 0,5 yrs before start
* Hormone therapies
* Malignant diseases
* Subjects were asked to avoid dietary supplements 4 weeks before and during the study.

Primary outcomes:
measure: microbiota structure, using 16 S ribosomal based gradient electrophoresis ( DGGE)
timeFrame: 7- 8 weeks hydro colon washes plus probiotic
measure: Gastrointestinal comfort, measured by Visual Analog Scale
timeFrame: 7- 8 weeks hydro colon washes plus probiotic
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Dep. for Nutritional Sciences, University of Vienna
state: Select your state
Study officials:
affiliation: UNIVIE
name: Alexander Haslberger
role: PRINCIPAL_INVESTIGATOR
References: