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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
Sponsor:
Information provided by (Responsible Party):
Univ. Doz. Dr. Alexander Haslberger, University of Vienna

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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Disease Other: Hydro Colon Therapy plus probiotic Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: N/A
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Locations
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Austria
Dep. for Nutritional Sciences, University of Vienna
Vienna, Select your state, Austria, 1090
Sponsors and Collaborators
University of Vienna
Investigators
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Principal Investigator: Alexander Haslberger UNIVIE
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Responsible Party: Univ. Doz. Dr. Alexander Haslberger, Univ. Dozent, University of Vienna
ClinicalTrials.gov Identifier: NCT02372201    
Other Study ID Numbers: MicrobColonIrrFFG2013
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 26, 2015
Last Verified: February 2015
Keywords provided by Univ. Doz. Dr. Alexander Haslberger, University of Vienna:
irritable bowel disease
microbiota
hydro colon therapy
food intolerance
Additional relevant MeSH terms:
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Intestinal Diseases
Irritable Bowel Syndrome
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases, Functional
Colonic Diseases