Effects of Fasting and Hydro Colon Therapy Plus Probiotics on GI Microbiota in Intolerances and Irritable Bowel Syndrome (MicFFGAH2013)
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|ClinicalTrials.gov Identifier: NCT02372201|
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Disease||Other: Hydro Colon Therapy plus probiotic||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|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 Start Date :||January 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||October 2014|
Experimental: Hydro Colon Therapy plus probiotic
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) [ Time Frame: 7- 8 weeks hydro colon washes plus probiotic ]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
- Gastrointestinal comfort, measured by Visual Analog Scale [ Time Frame: 7- 8 weeks hydro colon washes plus probiotic ]Gastrointestinal comfort was analysed by a standardised questionnaire. Pain was measured by Visual Analog Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372201
|Dep. for Nutritional Sciences, University of Vienna|
|Vienna, Select your state, Austria, 1090|
|Principal Investigator:||Alexander Haslberger||UNIVIE|