Ulcerative ColitisNCT00940576
Dietetic Efficacy of Mare's Milk for Patients With Chronic Inflammatory Bowel Diseases
A study testing mare´s milk in people with Ulcerative Colitis and Crohns Disease, run by University of Jena at 2 sites in Germany.
Trial summary
Mare's milk consumption could improve the well-being in patients with Crohn's disease and ulcerative colitis, respectively. Read more about this study
- Who is it for?
- Ages 10 to 50 years
- Conditions the study is for
- Ulcerative Colitis, Crohns Disease
- What is being tested?
- mare´s milk
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 2 sitesGermany
- Study dates
- Jul 2000to Feb 2001
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- clear and definite diagnosis of ulcerative colitis and Crohn's disease resp.
Who cannot join
- lactose intolerance and pregnancy
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Friedrich Schiller University Jena, Department of Nutritional Physiology
Jena, Thuringia, 07743
University of Jena, Institute of Nutrition, Department of Nutritional Physiology
Jena, Thuringia, D-07743
About this study
Official title: Dietetic Effects of Mare's Milk in Patients With Chronic Inflammatory Bowel Diseases (IBD) - a Double Blind Placebo Controlled Cross-over Study.
Mare's milk consumption could improve the well-being in patients with Crohn's disease and ulcerative colitis, respectively.
Read the detailed description
Background: Dietetic effects of mare's milk have been reported for a long time and can be based on bactericidal and immunological components of mare's milk.
Objective: Dietetic effects of oral intake of mare's milk in adolescent patients with chronic inflammatory bowel diseases were investigated.
Design: In a randomized, placebo-controlled, double-blind, cross-over intervention study, eight Crohn's disease patients and nine ulcerative colitis patients received daily 250 mL mare's milk or placebo drink.
- Conditions
- Ulcerative Colitis, Crohns Disease
- Being tested
- mare´s milk, placebo drink
- Keywords
- mare's milk, Crohn's disease, ulcerative colitis, clinical
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mare´s milkDietary supplement
oral intake of 250 ml mare's milk first, then placebo drink daily during 8 weeks of each (cross over design)
placebo drinkOther
oral intake of 250 ml placebo drink first, then mare's milk daily during 8 weeks of each (cross over design)
| Study group | Role | What they receive |
|---|---|---|
| mare´s milk | Experimental | oral intake of of 250 ml mare´s milk Receives: Dietary Supplement: mare´s milk; Other: placebo drink |
| placebo drink | Placebo comparator | oral intake of of 250 ml placebo drink Receives: Dietary Supplement: mare´s milk; Other: placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of Crohn´s Disease and/or Ulcerative Colitis
score for Crohn´s disease: Crohn´s Disease Activity Index (CDAI), < 150 = remission, 151-220 = moderate activity, 221-450 = severe activity; score for ulcerative colitis: Colitis Activity Index (CAI), 0-4 = remission, 5-9 = low activity, 10-16 = moderate activity, 17-23 = high activity.
Measured: 8 weeks
Secondary outcomes (1)
Extra-intestinal Pain
The patients recorded daily their extraintestinal disorders (fever, anal fissures, stomatitis, arthralgia, skin irritation) using a treatment improvement protocol (TIP).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study startJul 2000
- Primary completionFeb 2001
- Study completionFeb 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ulcerative ColitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Gerhard Jahreis, University of Jena
- Investigators
- Gerhard Jahreis, Prof. Dr., Principal investigator, Professor in Ordinary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940576
- Sponsor's protocol ID
- LSEP_H08b-00
- Status last verified
- May 2015
- First submitted
- 15 Jul 2009
- Last updated
- 25 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietetic Effects of Mare's Milk in Patients With Chronic Inflammatory Bowel Diseases (IBD) - a Double Blind Placebo Controlled Cross-over Study.
- ClinicalTrials.gov ID
- NCT00940576
- Acronym / sponsor ID
- LSEP_H08b-00
- Conditions
- Ulcerative Colitis, Crohns Disease
- Keywords
- mare's milk, Crohn's disease, ulcerative colitis, clinical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Jul 2000
- Primary completion
- Feb 2001 (actual)
- Study completion
- Feb 2001 (actual)
- First posted
- 16 Jul 2009 (estimated)
- Results
- Posted 20 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mare's milk consumption could improve the well-being in patients with Crohn's disease and ulcerative colitis, respectively.
Detailed description
Background: Dietetic effects of mare's milk have been reported for a long time and can be based on bactericidal and immunological components of mare's milk.
Objective: Dietetic effects of oral intake of mare's milk in adolescent patients with chronic inflammatory bowel diseases were investigated.
Design: In a randomized, placebo-controlled, double-blind, cross-over intervention study, eight Crohn's disease patients and nine ulcerative colitis patients received daily 250 mL mare's milk or placebo drink.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mare´s milk | Experimental | Dietary Supplement: mare´s milk, Other: placebo drinkoral intake of of 250 ml mare´s milk |
| placebo drink | Placebo comparator | Dietary Supplement: mare´s milk, Other: placebo drinkoral intake of of 250 ml placebo drink |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- clear and definite diagnosis of ulcerative colitis and Crohn's disease resp.
Key exclusion criteria (1 listed)
- lactose intolerance and pregnancy
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 |
|---|---|---|
| mare´s milkoral intake of 250 ml mare's milk first, then placebo drink daily during 8 weeks of each (cross over design) | Dietary supplement | mare´s milk, placebo drink |
| placebo drinkoral intake of 250 ml placebo drink first, then mare's milk daily during 8 weeks of each (cross over design) | Other | mare´s milk, placebo drink |
Primary outcome
Score of Crohn´s Disease and/or Ulcerative Colitis
Time frame: 8 weeks
score for Crohn´s disease: Crohn´s Disease Activity Index (CDAI), < 150 = remission, 151-220 = moderate activity, 221-450 = severe activity; score for ulcerative colitis: Colitis Activity Index (CAI), 0-4 = remission, 5-9 = low activity, 10-16 = moderate activity, 17-23 = high activity.
1 secondary outcome
Extra-intestinal Pain
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gerhard Jahreis, Prof. Dr. principal investigator
Professor in Ordinary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mare´s milk in people with Ulcerative Colitis and Crohns Disease, run by University of Jena at 2 sites in Germany.
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 1 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 25 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 20 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Score of Crohn´s Disease and/or Ulcerative Colitis (time frame: 8 weeks). 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 25 May 2015.