Travelan & Ulcerative Colitis

Phase 4

• Conditions: lcerative Colitis; Ulcerative Colitis; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12606000244505
• Lead Sponsor: Anadis Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Mild to moderate ulcerative colitis (UC)* diagnosed with UC at least 12 months previously* diagnosis on clinical grounds confirmed by colonoscopy within last 2 years* UC with a modified Mayo score >4.

Exclusion Criteria

Severe ulcerative colitis* any major gastrointestinal surgery* partial bowel obstruction* patients with co-existing non-intestinal inflammatory disease (eg disease assoc with elevated ESR)* pregnancy or breast feeding* alcohol or drug abuse* smoker* significant allergy to cow's milk* insistence on maintaining Probiotic intake during study* treated with oral steroids within 2 weeks of commencing screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
20% reduction in laboratory markers (serum inflammatory markers)[Measured at baseline then monthly. Outcome effect will be determined after 2 months intervention, then confirmed after a post-intervention observation period of one month.<br>That is: one month preintervention observation & measurement, 2 months intervention & measurement, one month post intervention observation & measurement.]

Secondary Outcome Measures

Name	Time	Method
20% reduction in symptoms according to patient's self assessment records[Measured at baseline, then after one month of pre-intervention observation. Outcomes determined after 2 months intervention & measuremnt then further reassessed after one month post intervention observation and measurements.];20% change in antibody levels within the gut (stool samples)[Measured at baseline, then after one month of pre-intervention observation. Outcomes determined after 2 months intervention & measuremnt then further reassessed after one month post intervention observation and measurements.];A reduction of faecal blood loss[Measured at baseline, then after one month of pre-intervention observation. Outcomes determined after 2 months intervention & measuremnt then further reassessed after one month post intervention observation and measurements.]