Pilot Study of the Efficacy of Pancreatic Enzyme Supplementation for Symptom Control in Celiac Disease Not Responding to the Gluten Free Diet
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change of Gastrointestinal Symptoms
研究概览
简要总结
The purpose of this protocol is to conduct a pilot study to investigate whether pancreatic enzyme supplementation will improve symptoms in individuals with celiac disease who suffer persistent symptoms despite a gluten free diet. This protocol specifically aims to:
- Evaluate the efficacy of pancreatic enzyme supplementation for reduction of gastrointestinal symptoms in patients with celiac disease on a gluten free diet.
- Assess the ability of fecal elastase levels to predict response to pancreatic enzyme supplementation in patients with celiac disease on a gluten free diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven celiac disease.
- •Ongoing symptoms defined as a CeD-GSRS score of greater than 3 during the run in period.
- •Subject must be following a gluten free diet.
- •tTG < 40 units at screening.
排除标准
- •Taking prescription or over the counter enzyme supplements for 1 month prior to enrollment.
- •Pregnant, breastfeeding or planning pregnancy. Woman using acceptable methods of contraception will be included. Acceptable methods of contraception include oral hormonal contraceptives, implanted hormonal contraceptives, diaphragm with spermicide, condoms, intra-uterine device, abstinence, and male partner vasectomy.
- •Patients with a pork allergy or who are unwilling to consume pork products.
- •English proficiency unsuitable for completion of surveys.
- •Known severe pancreatic disease.
- •Known history of prior cancer (except squamous or basal cell skin cancer).
- •Patients with lactose intolerance who are unable to tolerate a minimum of 1oz (2 tablespoons) of whole milk per day.
- •Clinically significant abnormality in safety lab values (i.e. CBC and BMP) at screening that may impact subject safety or the scientific integrity of the study.
- •Other known active GI condition including but not limited to inflammatory bowel disease, small intestine bacterial overgrowth, and obvious FODMAP intolerance.
- •History of all major gastrointestinal surgery other than appendectomy or cholecystectomy.
- •Comorbid condition that in the opinion of the investigator would interfere with the subject's participation in the study or would confound the results of the study.
研究组 & 干预措施
PES, Then Placebo
Participants first received Pancreatic Enzyme Supplementation (PES) for 10 days. PES taken 6 times daily with gluten free meals and snacks. To facilitate duodenal digestion Omeprazole (20 mg/QD) was co-administered. After a washout period of 1 week, they then received placebo tablets (matching PES treatment) 6 times daily for 10 days.
干预措施: pancrelipase (Drug)
Placebo, Then PES
Participants first received placebo tablets (matching PES) for 10 days. Placebo was taken 6 times daily with gluten-free meals and snacks. To facilitate duodenal digestion Omeprazole (20 mg/QD) was co-administered. After a washout period of 1 week, they then received PES tablets six times daily for 10 days.
干预措施: pancrelipase (Drug)
结局指标
主要结局
Change of Gastrointestinal Symptoms
时间窗: Measured at end of each 10- day treatment period
The average per individual subject on-treatment score in the Celiac Disease Gastrointestinal Symptom Rating Scale (CeD GSRS) domains of Diarrhea, Indigestion, and Abdominal pain comparing active treatment to placebo (i.e. a paired comparison of CeD GSRS on treatment versus on placebo for each subject). CeD-GSRS: Each individual sub-section of the 15 sub-sections scores from 1 to 7, with greater scores indicating worse symptoms. A total score can range from 15 -105. This is then divided by 15 to obtain the minimum overall CeD-GSRS score of 1 and maximum of 7. It has 3 domains- Abdominal pain, Indigestion and Diarrhea domains, each domain having a score ranging from 1-7. The higher the overall score, the more severe the symptoms.
次要结局
- Correlation of Baseline Fecal Elastase and Celiac Disease Gastrointestinal Symptom Response at End of PES Treatment(Baseline visit (fecal elastase levels measured) and end of PES treatment period (CeD-GSRS scores measured))
- Change in Celiac Symptom Index Scores(Measured at the end of each 10-day treatment period)
研究者
Ciaran Kelly
Professor of Medicine
Beth Israel Deaconess Medical Center