Clinical Trials
The efficacy and safety of GluteGuard were demonstrated in double-blind, randomised, placebo-controlled trials conducted on 20 coeliac disease patients in clinical remission, and 20 dermatitis herpetiformis patients in clinical remission.
Both studies supported the use of GluteGuard enzyme supplementation as a safeguard for patients on a nominal gluten-free diet, affording significant protection against adverse symptoms induced by gluten challenge.
Caricain supplementation in Coeliac Disease
A double-blind, randomised clinical trial was carried out using GluteGuard compared with placebo. The trial recorded symptoms daily in 20 individuals with coeliac disease while being challenged with one gram of gluten for 42 days. Small bowel histology was monitored at the start and end of the study.
- Those taking GluteGuard were significantly less likely to report symptoms of celiac disease than the placebo group (28 vs. 118; p<0.01).
- 35.7% (5/14) of patients taking GluteGuard reported that they had no symptoms at the end of the trial, whilst 50% (7/14) reported only mild symptoms.
- 4 of the 6 (67%) patients in the placebo group and 1 of 14 (7%) in the treatment group) withdrew in the first 14 days due to symptoms from the gluten challenge.
- No detrimental changes in small bowel histology for the treatment group, despite 42 days of gluten challenge.
85%
of the treatment group reported no or only mild symptoms despite gluten challenge.
67%
of the placebo group were unable to complete gluten challenge due to the symptoms experienced.
93%
of the treatment group was protected by GluteGuard
The Effect of Enzyme Supplementation on Symptoms and Duodenal Histology in Coeliac Patients
A second double-blind, randomised, placebo-controlled trial recorded and graded daily symptoms in 20 coeliac disease (CD) patients (aged 18 to 70) in clinical remission being challenged with one gram of gluten daily for 42 days.
This trial aimed to determine whether GluteGuard was able to break down the harmful gluten peptides before they could cause CD symptoms or lead to histologically significant damage. All patients maintained their regular gluten-free diet for the duration of the trial.
The 14 therapy group patients took GluteGuard orally immediately prior to consuming gluten in the form of commercial wheat biscuits at breakfast each day. Small bowel histology was monitored at the beginning and end of the study.
- The trial showed that oral enzyme therapy with GluteGuard was effective in preventing the symptoms induced by gluten challenge in CD individuals, with a statistically significant difference between treatment and placebo after 14 days. General wellbeing also improved in the therapy group.
- Four of the six placebo group patients (67%) and one therapy group patient (7%) withdrew after 14 days due to development of symptoms. For the therapy group, there were no significant changes in markers of histological damage or biopsy reports after 42 days of gluten challenge.
- Those taking GluteGuard were significantly less likely to report CD symptoms than the placebo group (28 vs 118; p<0.01). Five of the 14 therapy group patients (37.5%) reported that they had no symptoms at the end of the trial; a further seven (50%) reported mild symptoms.
- Importantly, mucosal damage was not exacerbated in therapy group patients despite 42 days of daily gluten challenge.
Caricain supplementation in Dermatitis Herpetiformis
A second study investigated the effectiveness of GluteGuard in participants with dermatitis herpetiformis. Patients with the condition suffer an itchy, blistering and burning skin rash triggered by gluten. The 20 participants in this trial were in clinical remission and following a gluten-free diet. The volunteers consumed six grams of gluten daily for fourteen days, with ten concurrently taking GluteGuard tablets and ten taking placebo.
After 7 days, the major symptoms associated with dermatitis herpetiformis were more severe and more common in the placebo group compared with enzyme therapy group.
High titres of IgA EmA antibodies in 8 patients at the start of the trial indicated a degree of non-compliance with a gluten-free diet. Of these, 5 patients in the treatment group demonstrated lower titres after 14 days, suggesting the benefit of enzyme therapy in addition to the normal gluten-free diet for patient wellbeing.
81%
Reduction in area of skin lesions
38%
reduced itchiness
71%
Fewer skin lesions
The findings of this study emphasise the effective protection GluteGuard provides against skin symptoms. The differences in size and area of skin lesions provided a measurable and reliable outcome.
The Effect of Enzyme Therapy on Skin Symptoms and Immune Responses in Patients with Dermatitis Herpetiformis
The first double-blind, randomised, placebo-controlled trial challenged 20 dermatitis herpetiformis (DH) patients (aged 18-70) in clinical remission with six grams of gluten daily for 14 days. All patients maintained their regular gluten-free diet for the duration of the trial.
This trial focused on skin indicators that were relatively easy to measure, rather than relying solely on symptoms reported by participants. DH is considered a specific cutaneous manifestation of CD. The 10 therapy group patients took two GluteGuard tablets orally three times a day, immediately prior to consuming gluten in the form of commercial wheat biscuits at breakfast, lunch and dinner.
Symptoms and signs of skin involvement were recorded and graded at the start of the trial, after seven days on the gluten challenge, and again after 14 days. Blood samples taken at the start and finish of the trial were assayed for IgA EmA and anti-gliadin antibodies.
- Abnormally high antibody titres of both types in eight patients at the start of the trial indicated a degree of non-compliance with a gluten-free diet, which reflects the high degree of gluten exposure amongst people following strict GF diets[1]. This may be partly due to gluten contamination in otherwise gluten-free foods.
- After seven days, the major symptoms associated with DH were more severe and more common in the placebo group compared with the therapy group. Six of the 10 placebo patients (60%) were unable to complete the gluten challenge due to the severity of their symptoms.
- Compared to the placebo group, after seven days the therapy group had one-fifth the area of skin lesions, less than one-third the number of skin lesions, and around half the itchiness score.
- Five therapy group patients who had high IgA EmA and gliadin antibody titres at the start of the trial demonstrated lower titres after 14 days, suggesting the benefit of enzyme therapy with GluteGuard in addition to the normal gluten-free diet for patient wellbeing.
[1] “Symptomatic reactions to suspected gluten exposure [are] common among patients with coeliac disease on a gluten-free diet and frequently experienced in the context of eating at restaurants or other peoples’ homes” (Silvester et al. (2016) Aliment Pharmacol Ther. 44(6): 612–619)
[2] Cornell H. J., Czyzewska A., Macrae F. A. et al. (2016) The effect of enzyme supplementation on symptoms and duodenal histology in celiac patients. Int. J. Celiac Disease 4(2), pp.40-7.