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

Last updated: October 13, 2021
Sponsor: 9Meters Biopharma
Overall Status: Active - Recruiting

Phase

3

Condition

Celiac Disease

Treatment

N/A

Clinical Study ID

TX284467
CED-LA-3001
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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).

Study Design

Study Start date:
October 12, 2021
Estimated Completion Date:

Study 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.

Connect with a study center

  • Mid Hudson Medical Research, PLLC

    New Windsor, New York 12553
    United States

    Active - Recruiting

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