Irritable Bowel DiseaseMicFFGAH2013NCT02372201
Effects of Fasting and Hydro Colon Therapy Plus Probiotics on GI Microbiota in Intolerances and Irritable Bowel Syndrome
A study testing Hydro Colon Therapy plus probiotic in people with Irritable Bowel Disease, run by University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Disease
- What is being tested?
- Hydro Colon Therapy plus probiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects under consultation at doctors or nutritionists for Inflammatory Bowel Syndrome (IBD) of food intolerances
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Dep. for Nutritional Sciences, University of Vienna
Vienna, Select Your State, 1090
About this study
Official title: Effects of Fasting and Hydro Colon Therapy Plus Probiotics on Abundance and Diversity of 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.
Read the 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.
- Conditions
- Irritable Bowel Disease
- Being tested
- Hydro Colon Therapy plus probiotic
- Keywords
- irritable bowel disease, microbiota, hydro colon therapy, food intolerance
- Medical subject headings
- Irritable Bowel Syndrome, Food Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydro Colon Therapy plus probioticOther
Probiotic intervention was done after 2-5 cycles of hydro colon therapy.
| Study group | Role | What they receive |
|---|---|---|
| Hydro Colon Therapy plus probiotic | Experimental | Hydro Colon therapy including 2-5 washes in 3 weeks, probiotic intervention for 5 weeks after end of hydro Colon therapy Receives: Other: Hydro Colon Therapy plus probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
microbiota structure, using 16 S ribosomal based gradient electrophoresis ( DGGE)
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
Measured: 7- 8 weeks hydro colon washes plus probiotic
Gastrointestinal comfort, measured by Visual Analog Scale
Gastrointestinal comfort was analysed by a standardised questionnaire. Pain was measured by Visual Analog Scale
Measured: 7- 8 weeks hydro colon washes plus probiotic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startJan 2013
- Primary completionJun 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Univ. Doz. Dr. Alexander Haslberger, University of Vienna
- Investigators
- Alexander Haslberger, Principal investigator, UNIVIE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02372201
- Sponsor's protocol ID
- MicrobColonIrrFFG2013
- Acronym
- MicFFGAH2013
- Status last verified
- Feb 2015
- First submitted
- 12 Jan 2015
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fasting and Hydro Colon Therapy Plus Probiotics on Abundance and Diversity of GI Microbiota in Intolerances and Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT02372201
- Acronym / sponsor ID
- MicFFGAH2013 / MicrobColonIrrFFG2013
- Conditions
- Irritable Bowel Disease
- Keywords
- irritable bowel disease, microbiota, hydro colon therapy, food intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of ViennaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydro Colon Therapy plus probiotic | Experimental | Other: 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 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects under consultation at doctors or nutritionists for Inflammatory Bowel Syndrome (IBD) of food intolerances
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydro Colon Therapy plus probioticProbiotic intervention was done after 2-5 cycles of hydro colon therapy. | Other | Hydro Colon Therapy plus probiotic |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Haslberger principal investigator
UNIVIE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydro Colon Therapy plus probiotic in people with Irritable Bowel Disease, run by University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microbiota structure, using 16 S ribosomal based gradient electrophoresis ( DGGE) (time frame: 7- 8 weeks hydro colon washes plus probiotic). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2015.