Menu
Clinical trials
Our Clinical Research
GluteGuard
The Effect of Enzyme Supplementation on Symptoms and Duodenal Histology in Coeliac Patients
A randomised, double-blind clinical trial was carried out using enteric coated tablets containing Caricain compared with placebo.
Study Objective: To determine if enzyme therapy was able to protect coeliac patients against the histological damage and frequency of symptoms caused by daily ingestion of gluten when compared with placebo.
Design:
- 20 patients with coeliac disease were challenged with 1g of gluten per day (2 wheat biscuits) for 42 days.
- Patients were randomised into two groups: 14 were administered caricain before the gluten challenge and 6 were administered placebo.
- Intestinal biopsies and TtG-IgA antibodies were assessed prior and after the 42-day gluten challenge.
Results
- Those taking caricain were significantly less likely to report symptoms of coeliac disease than placebo (p<0.01).
- 67% of the placebo group abandoned the gluten challenge due to the severity of symptoms. Whereas, 86% of patients in the treatment group completed the 42-day gluten challenge with mild or no symptoms.
- Patients in the treatment group reported a higher feeling of well-being than the placebo group (p<0.01).
- No adverse effects to caricain were recorded during the trial;
- Despite a 42-day gluten challenge, no significant changes in small bowel histology were observed in the caricain treatment group.
Conclusion: Enzyme supplementation with Caricain was able to significantly protect coeliac patients from the adverse symptoms induced by the gluten challenge and helped to maintain overall wellbeing.
Statistical Significance
A statistical analysis of symptoms scores at day-14 showed significant results favouring enzyme therapy*:
Fatigue: p=0.012, favouring enzyme therapy.
Stomach pain: p= 0.007, favouring enzyme therapy.
Nausea/vomiting: p= 0.018, favouring enzyme therapy.
Stomach cramps: p= 0.003, favouring enzyme therapy.
General well-being: p= 0.007, favouring enzyme therapy.
Stomach bloat: p = 0.329 -not statistically significant- favours enzyme therapy.
GluteGuard
The Effect of Enzyme Therapy on Skin Symptoms and Immune Responses in Patients with Dermatitis Herpetiformis
A randomised, double-blind clinical trial was carried out using enteric coated tablets containing Caricain compared with placebo. Patients with dermatitis herpetiformis (DH) suffer an itchy, blistering and burning skin rash triggered by gluten.
Objective: To determine if caricain supplementation could protect patients with DH against skin symptoms caused by the consumption of wheat gluten.
Design:
- 20 patients diagnosed with DH (in clinical remission and following a gluten free diet) were randomised into two groups: 10 were administered enzyme therapy before the gluten challenge and 10 were administered placebo.
- Patients were challenged with 6g of daily gluten for 14 days.
- Patients recorded timing and graded the discomfort of skin itch and/or burning on a linear scale from 0 to 10.
- Severity and area of skin lesions were assessed by the supervising investigator throughout the trial.
- Blood samples were taken at the start and after 14 days and assayed for IgA EmA antibodies and anti-gliadin antibodies.
Results
- After 7 days, the major symptoms associated with DH were more severe and more common in the placebo group compared with the treatment group. As a result, 60% of the placebo group abandoned the gluten challenge due to the severity of symptoms.
- 90% of patients in the reatment group completed the 14-day gluten challenge.
- The mean scores for area of skin symptoms were significantly reduced in the treatment group
- No adverse effects from Caricain supplementation were recorded during the trial.
Conclusion: Enzyme supplementation with Caricain offered protection to patients with suffering from dermatitis herpetiformis from the effects of a daily gluten challenge. The most significant outcome was a reduced area of skin lesions when compared with placebo.