Research study for individuals with Celiac symptoms despite a Gluten Free Diet

  • STATUS
    Recruiting
  • sponsor
    9Meters Biopharma
Updated on 13 October 2021
body mass index
bloating
diarrhea
endoscopy
investigational drug
abdominal pain
gluten

Summary

Currently, the only treatment to manage celiac disease symptoms is maintaining a gluten-free diet. Many people with celiac disease continue to have symptoms even while following a strict gluten-free diet. The CeDLara study is being conducted to determine if an investigational drug reduces symptoms of celiac disease when taken while maintaining a gluten-free diet. 

This study is currently recruiting eligible participants. If you qualify to take part in this research study and agree to participate, the study will include 8 visits to a study site near you. Study visits are similar to a doctor’s appointment. Your time and travel will be reimbursed. Learn more about the study protocol in the FAQ section below.

CeDLara study sites are following local COVID-19 safety standards and guidelines to keep participants safe, such as mask wearing, increased surface cleaning, social distancing, as well as other activities.

Description

In order to qualify for the CeDLara study, certain criteria must be met. Some of the basic criteria are listed below.
  • Are 18 years old or older
  • Were diagnosed with Celiac Disease more than 6 months ago
  • Are actively experiencing symptoms related to Celiac Disease
  • Have been on a gluten-free diet for at least 6 months
Other criteria must be met to participate. A study doctor will need to perform various health tests and examinations to confirm if you are able to participate in the CeDLara study.

There is no cost to you to participate in this study. Health insurance is not required to participate.

Details
Condition GFD, Gluten, Celiac Disease
Clinical Study IdentifierTX284467
Sponsor9Meters Biopharma
Last Modified on13 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥18
BMI (Body Mass Index) between 16-45
Diagnosis of Celiac Disease >6 months from screening based on previous endoscopy and bloodwork
Currently on Gluten Free Diet for at least 6 months and still experiencing symptoms of Celiac Disease, such as abdominal pain, cramping, bloating, gas, diarrhea, loose stool or nausea
If of childbearing potential, must agree to suitable contraception methods

Exclusion Criteria

Currently or plan to be pregnant or lactating
Diagnosis of refractory Celiac disease
Diagnosis of any other active GI disease (ie, Crohn's, ulcerative colitis, gastritis, etc)
Diagnosis of Type 1 Diabetes or Uncontrolled Type 2 Diabetes
Diagnosis of autoimmune disorders
Uncontrolled thyroid disease
Receipt of antibiotics within 4 weeks of screening
History of drug or alcohol abuse in the past year
Diagnosis of cancer within the previous 5 years (excluding non-melanoma skin cancer, cervical cancer or early stage prostate cancer successfully treated at least 1 year prior to study entry)
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

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