Travelan & Ulcerative Colitis

An open label study to assess the efficacy of Travelan as an adjunct therapy to reduce inflammation in Ulcerative Colitis

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000244505

Enrollment

Registered

2006-06-19

Start date

2006-08-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will investigate the effectiveness of Travelan, given alongside a patient's current medications, to reduce inflammation in ulcerative colitis. Travelan is a hyper-immune bovine colostrum extract from cows that have been vaccinated against the agents which commonly cause travellers diarrhoea. (ie a variety of E.Coli's). Travelan is currently sold as an over-the-counter medication in Australia to reduce the risk of traveller's diarrhoea. Medical Practitioners report that patients with a variety of chronic diarrhoea syndromes have a reduction in symptoms when taking Travelan to avoid traveller's diarrhoea. The 4 month pilot-study will review symptoms, blood and stool samples to evaluate if 2 months intervention with Travelan has an effect on bowel inflammation in ulcerative colitis.

Interventions

ravelan tablets 200mg x 6 daily (3TDS) orally for 2 months. Participants have: Baseline measurements one month pre-intervention observation, two months intervention, then one month post-intervention observation. Data gathered during the initial month of observation allows each individual to act as his own control.

Study design

Allocation

Non-randomised trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

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.

Outcome results