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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Gio Carlo
Quiambao
quiambao.giocarlo@nhs.net
Gio Carlo
Quiambao
quiambao.giocarlo@nhs.net
Prof
Qasim
Aziz
q.aziz@qmul.ac.uk
Congenital malformations and deformations of the musculoskeletal systemDiseases of oesophagus, stomach and duodenum
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Background: Hypermobile Ehlers-Danlos Syndrome (hEDS) is a connective tissue condition that causes very flexible joints,stretchy skin,and fragile tissues. Many people with hEDS also experience digestive (GI) symptoms like bloating,nausea,or discomfort after eating,which can affect daily life. However,the exact reasons behind these digestive problems are not yet well understood.
Study Aim: The DIGEST-hEDS study aims to explore why people with hEDS have digestive issues,focusing on how their bodies react to food and what biological factors may be involved.
Study Design: We will include 216 participants,divided into four groups:
- 108 people with both hEDS and Functional Dyspepsia (FD),a condition causing long-term upper stomach discomfort.
- 36 people with hEDS but no FD.
- 36 people with FD but no hEDS.
- 36 healthy people without hEDS or FD.
Methods
Participants will take part in:
- Clinical Assessments: Sharing their medical history and describing their GI symptoms.
- Physiological Tests: Measuring how their stomach empties food and how their gut works.
- Molecular Analyses: Providing blood and tissue samples to look for immune responses,allergies,and pain-related markers.
- Potential Benefits
By identifying what causes digestive symptoms in hEDS,this study hopes to:
- Improve understanding of the connection between hEDS and digestive disorders.
- Support the development of better,more specific treatments to help improve quality of life.
Conclusion: The DIGEST-hEDS study is a thorough investigation into the digestive health challenges faced by people with hEDS. By combining clinical,physiological,and laboratory insights,we aim to uncover the causes of these symptoms and open the door to better management strategies.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Cross-sectional;
You can take part if:
You may not be able to take part if:
• Participant who is unwilling or unable to provide informed consent. • Vulnerable individuals • Participant who unable to consume a nutrient drink as required by the study protocol. • Participant who is currently pregnant or within 6 months postpartum. • Participant who is breastfeeding. • Participant with BMI<15. • Participant who is on enteral or parenteral nutrition (clinically assisted nutrition and hydration). • Participant with clinically significant gallstone disease e.g. multiple gall stones,inflamed or thickened gall bladder wall,history of biliary colic or cholecystitis not yet treated with a cholecystectomy,• Participant with a history of upper gastrointestinal surgeries,including gastric,oesophageal,duodenal,or Nissen fundoplication procedures and any other major upper GI surgery. • Participant with a history of G-POEM or pyloric dilatation. • Participant diagnosed with major oesophageal motility disorder. • Participant with a history of small intestinal or colonic surgery (relevant for visit B) or other abdominal or pelvic surgeries,including cholecystectomy - will be evaluated by the study team to determine eligibility on a case-by-case basis. • Participant with a history or current diagnosis of upper gastrointestinal cancer. • Participant currently undergoing active treatment (chemotherapy / radiotherapy) for non-upper gastrointestinal cancer. • Participant diagnosed with active Coeliac disease. • Participant diagnosed with Crohn’s disease. • Participant diagnosed with any inflammatory connective tissue disease. • Participant with any life-threatening medical condition. • Participant with diabetes mellitus. • Participant using opiates exceeding an oral Morphine equivalent of 10 mg,e.g 100 mg Codeine. • Participant who is not stable on their relevant medications (such as neuromodulators) for the last 3 months. • Participant who is unable to stop GI related medications prior to study visits (e.g. PPI,Metoclopramide,NSAIDs,etc). • Participants with a history of intravenous drug use (IVDU),or use of substances such as cocaine,LSD,or ketamine. • Cannabis use is not an exclusion criterion,but participants must discontinue use 2 weeks before study visits.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Qasim
Aziz
q.aziz@qmul.ac.uk
Gio Carlo
Quiambao
quiambao.giocarlo@nhs.net
Gio Carlo
Quiambao
quiambao.giocarlo@nhs.net
The study is sponsored by Queen Mary University of London and funded by The Ehlers-Danlos Society .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 68380
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