Irritable Bowel Disease Clinical Trial
Official title:
Effects of Fasting and Hydro Colon Therapy Plus Probiotics on Abundance and Diversity of GI Microbiota in Intolerances and Irritable Bowel Syndrome
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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