An interventional study of Hydro Colon Therapy plus probiotic in Irritable Bowel Disease, sponsored by University of Vienna. Completed at 1 site in Austria. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-26.
Sponsored by University of Vienna · Not applicable, Interventional, and Basic science
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.
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.
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This study's enrollment of 68 is close to the median of 70 across 552 interventional studies indexed under Intestinal Diseases.
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Exclusion Criteria:
Hydro Colon therapy including 2-5 washes in 3 weeks, probiotic intervention for 5 weeks after end of hydro Colon therapy
Other: Hydro Colon Therapy plus probiotic
Probiotic intervention was done after 2-5 cycles of hydro colon therapy.
microbiota structure, using 16 S ribosomal based gradient electrophoresis ( DGGE)
Microbiota were analysed for abundance of main microbiota groups and microbiota diversity using 16 S ribosomal based gradient electrophoresis ( DGGE). Abundance is shown in DNA copies/g feces; diversity as number of bands/ sample and by bioinformatic analysis
Time frame: 7- 8 weeks hydro colon washes plus probiotic
Gastrointestinal comfort, measured by Visual Analog Scale
Gastrointestinal comfort was analysed by a standardised questionnaire. Pain was measured by Visual Analog Scale
Time frame: 7- 8 weeks hydro colon washes plus probiotic
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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University of Vienna