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Completed

NCT Number: NCT02372201

Effects of Fasting and Hydro Colon Therapy Plus Probiotics on 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.

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Key information

Conditions

Irritable Bowel Disease Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Food Intolerance Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dep. for Nutritional Sciences, University of Vienna

Vienna, Select Your State, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydro Colon Therapy plus probiotic

Other

Probiotic intervention was done after 2-5 cycles of hydro colon therapy.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Vienna

Other

Registry information

Official study title

Effects of Fasting and Hydro Colon Therapy Plus Probiotics on Abundance and Diversity of GI Microbiota in Intolerances and Irritable Bowel Syndrome

Acronym: MicFFGAH2013

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 26, 2015
Registry last updated
Feb 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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