Gluten Related Disorders in Barrett's Esophagus
Ključne besede
Povzetek
Opis
Perhaps patient's with gluten related disorders develop Barrett's esophagus due to non-acid reflux precipitated by upper gastrointestinal motility changes that respond to a gluten free diet; whereas patients without gluten related disorders develop Barrett's due to the accepted mechanism of acid reflux.
The primary objectives are to explore if patients with gluten-related disorders (CD and GS) may have an altered mechanism of developing Barrett's esophagus typified by increased alkali reflux compared to those without gluten-related disorders; and to determine if this mechanism (altered motility and increased non-acid reflux) responds to a gluten free diet.
Specific objectives include assessing whether patients with GRD and Barrett's esophagus have altered esophageal reflux extent, frequency, and type (assessed by pH-impedance); altered symptom profiles; differential esophageal body and sphincter pressures (assessed by manometry); aberrant gastroduodenal motility (assessed by videofluoroscopy) in comparison to patients with BE and no GRD. Finally a gluten free diet will be instituted to assess whether a gluten-free diet alters esophageal reflux extent, frequency, and type or symptom profiles in those with BE with and without a GRD.
Datumi
| Nazadnje preverjeno: | 09/30/2017 |
| Prvič predloženo: | 10/17/2017 |
| Predviden vpis oddan: | 10/29/2017 |
| Prvič objavljeno: | 11/05/2017 |
| Zadnja posodobitev oddana: | 03/19/2018 |
| Zadnja posodobitev objavljena: | 03/20/2018 |
| Dejanski datum začetka študija: | 03/31/2018 |
| Predvideni datum primarnega zaključka: | 09/29/2018 |
| Predvideni datum zaključka študije: | 12/29/2018 |
Stanje ali bolezen
Intervencija / zdravljenje
Other: Gluten free diet
Faza
Skupine rok
| Roka | Intervencija / zdravljenje |
|---|---|
| Experimental: Subjects with GRDs An intervention of a change in diet, specifically a gluten free diet taught by a health care professional will be administered for one month's time. | |
| Active Comparator: Subjects without GRDs An intervention of a change in diet, specifically a gluten free diet taught by a health-care professional will be administered for one month's time. |
Merila upravičenosti
| Starost, primerna za študij | 18 Years Za 18 Years |
| Spol, upravičen do študija | All |
| Sprejema zdrave prostovoljce | Da |
| Merila | Inclusion Criteria: - Aged 18 years and over - Barrett's Esophagus diagnosis based on endoscopy and esophageal biopsies - Patients able to comply to the study procedures, according to the investigator's own judgment Exclusion Criteria: - Patients who have been on a gluten free diet within the last six months - History of bariatric surgery, fundoplication, or gastrectomy (partial or complete) - Connective tissue disease - Concurrent organic GI pathology other than benign polyps, haemorrhoids, lipomas, H. pylori infection, diverticulosis, and melanosis coli - Chronic treatment with high dose opioids - Alcohol or drug abuse - Pregnant or breastfeeding women. Women enrolling in the study will be advised to avoid pregnancy during the course of the study by using adequate birth control such as abstinence, oral contraceptive pill, barrier contraceptives (i.e condom). If a subject becomes pregnant she will be withdrawn from the study. - Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be a risk or that could interfere with data collection |
Izid
Primarni izidni ukrepi
1. Ratio of non-acidic to acidic reflux events [At study start and at one month after a gluten free diet]
Ukrepi sekundarnega rezultata
1. Reflux disease questionnaire [At study start and one month after a gluten free diet]
2. Esophageal motility [At study start]
3. Upper gastrointestinal motility [At study start]
4. Leeds short form questionnaire [At study start and one month after a gluten free diet]
5. Gastroesophageal reflux disease-health related quality of life instrument [At study start and one month after a gluten free diet]
