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

NCT ID: NCT02372201

Last Updated: 2015-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Irritable Bowel Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Hydro Colon Therapy plus probiotic

Intervention Type OTHER

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

Interventions

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Hydro Colon Therapy plus probiotic

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Univ. Doz. Dr. Alexander Haslberger

Univ. Dozent

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexander Haslberger

Role: PRINCIPAL_INVESTIGATOR

UNIVIE

Locations

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Dep. for Nutritional Sciences, University of Vienna

Vienna, Select Your State, Austria

Site Status

Countries

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Austria

Other Identifiers

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MicrobColonIrrFFG2013

Identifier Type: -

Identifier Source: org_study_id

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