BACKGROUND & AIMS:
There is debate over the existence of nonceliac gluten sensitivity (NCGS) -intestinal and extra-intestinal symptoms in response to ingestion of gluten-containing foods by people without celiac disease or wheat allergy. We performed a randomized, double-blind, placebo-controlled, cross-over trial to determine the effects of administration of low doses of gluten to subjects with suspected NCGS.
METHODS:
We enrolled 61 adults without celiac disease or wheat allergy who believe ingestion of gluten-containing food to be the cause of their intestinal and extra-intestinal symptoms. Participants were randomly assigned to groups given either 4.375 g/day gluten or rice starch (placebo) for 1 week, each via gastro-soluble capsules. After a 1 week of gluten-free diet, participants crossed over to the other group. The primary outcome was the change in overall (intestinal and extra-intestinal) symptoms, determined by established scoring systems, between gluten and placebo intake. A secondary outcome was the change in individual symptom scores between gluten vs placebo.
RESULTS:
According to the per-protocol analysis of data from the 59 patients who completed the trial, intake of gluten significantly increased overall symptoms compared with placebo (P=.034). Abdominal bloating (P=.040) and pain (P=.047), among the intestinal symptoms, and foggy mind (P=.019), depression (P=.020), and aphthous stomatitis (P=.025), among the extra-intestinal symptoms, were significantly more severe when subjects received gluten than placebo.
CONCLUSIONS:
In a cross-over trial of subjects with suspected NCGS, the severity of overall symptoms increased significantly during 1 week of intake of small amounts of gluten, compared with placebo. Clinical trial no: ISRCTN72857280.
→ source (external link)There is debate over the existence of nonceliac gluten sensitivity (NCGS) -intestinal and extra-intestinal symptoms in response to ingestion of gluten-containing foods by people without celiac disease or wheat allergy. We performed a randomized, double-blind, placebo-controlled, cross-over trial to determine the effects of administration of low doses of gluten to subjects with suspected NCGS.
METHODS:
We enrolled 61 adults without celiac disease or wheat allergy who believe ingestion of gluten-containing food to be the cause of their intestinal and extra-intestinal symptoms. Participants were randomly assigned to groups given either 4.375 g/day gluten or rice starch (placebo) for 1 week, each via gastro-soluble capsules. After a 1 week of gluten-free diet, participants crossed over to the other group. The primary outcome was the change in overall (intestinal and extra-intestinal) symptoms, determined by established scoring systems, between gluten and placebo intake. A secondary outcome was the change in individual symptom scores between gluten vs placebo.
RESULTS:
According to the per-protocol analysis of data from the 59 patients who completed the trial, intake of gluten significantly increased overall symptoms compared with placebo (P=.034). Abdominal bloating (P=.040) and pain (P=.047), among the intestinal symptoms, and foggy mind (P=.019), depression (P=.020), and aphthous stomatitis (P=.025), among the extra-intestinal symptoms, were significantly more severe when subjects received gluten than placebo.
CONCLUSIONS:
In a cross-over trial of subjects with suspected NCGS, the severity of overall symptoms increased significantly during 1 week of intake of small amounts of gluten, compared with placebo. Clinical trial no: ISRCTN72857280.
