MicFFGAH2013: Effects of Fasting and Hydro Colon Therapy Plus Probiotics on GI Microbiota in Intolerances and Irritable Bowel Syndrome

Sponsor

University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT02372201

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

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 :

Jan 1, 2013

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.