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

NCT02372201 — Not applicable, Completed, 68 participants, University of Vienna

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

RegistryNCT02372201, acronym MicFFGAH2013
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, basic science
Enrollment68 (Actual)
SponsorUniversity of Vienna (Other)
ConditionsIrritable Bowel Disease
InterventionsHydro Colon Therapy plus probiotic (Other)
Datesstart 2013-01-01, primary completion 2014-06-01, completion 2014-10-01, first posted 2015-02-26, last updated 2015-02-26
Locations1 site in Austria

Related Papers Related Patents Related Grants Related Experts
All trials for Irritable Bowel Disease All trials of Hydro Colon Therapy plus probiotic

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Hydro Colon Therapy plus probioticExperimentalOther: Hydro Colon Therapy plus probioticHydro Colon therapy including 2-5 washes in 3 weeks, probiotic intervention for 5 weeks after end of hydro Colon therapy
  • Hydro Colon Therapy plus probiotic (Other): Probiotic intervention was done after 2-5 cycles of hydro colon therapy.

+Outcome measures

Primary outcomes

  • microbiota structure, using 16 S ribosomal based gradient electrophoresis ( DGGE) [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 [7- 8 weeks hydro colon washes plus probiotic]: Gastrointestinal comfort was analysed by a standardised questionnaire. Pain was measured by Visual Analog Scale

+Eligibility

Sex: All, ages: 20 Years to 50 Years, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
Dep. for Nutritional Sciences, University of ViennaVienna, Select Your StateAustria

+Investigators