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Efficacy of Probiotic ES1 for the Treatment of Non-Celiac Gluten Sensitivity

E

Exzell Pharma

Status and phase

Unknown
Phase 2

Conditions

Non-Celiac Gluten Sensitivity

Treatments

Other: Placebo
Other: Probiotic ES1

Study type

Interventional

Funder types

Industry

Identifiers

NCT02810301
EX-ES01

Details and patient eligibility

About

Study to demonstrate the efficacy of Probiotic ES1 in alleviating symptoms of gluten sensitivity in non-celiac gluten sensitive subjects exposed to a small, fixed amount of gluten.

Full description

This is a randomized, double-blind, placebo-controlled study. Sixty non-celiac gluten sensitive subjects will be randomized into one of two groups; Probiotic ES1 or placebo. For the duration of the study, subjects must adhere to a gluten-free diet, apart from a scheduled fixed gluten exposure of two slices of bread once daily. Subjects will be required to take 1 capsule before and after consuming the two slices of bread and score the severity of their symptoms in a diary provided for the duration of the study (7 days).

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age: 18-65
  • Male or non-pregnant, non-lactating females.
  • Documented or self-diagnosed gluten sensitivity that is well-controlled.
  • Negative celiac serology to eliminate Celiac Disease at screening.
  • Written informed consent prior to any screening procedure.
  • Ability and willingness to comply with study requirements.
  • Adherence to a gluten-free diet during period of the study and 1 week prior to the first dose.
  • BMI < 35 kg/m2.

Exclusion criteria

  • History of diagnosis of Celiac Disease.
  • Positive pregnancy test at screening.
  • Positive HIV, Hepatitis, or Tuberculosis infection.
  • History of substance abuse within last 5 years.
  • Alcohol consumption of > 2 standard drink equivalents per day.
  • Recent myocardial infarction within past 3 months, recent stroke within past 12 months, recent abdominal surgery within past 12 months, history of any malignancies and/or active treatment for a psychiatric disorder.
  • Use of systemic biologics within 6 months of the study.
  • Use of oral probiotics within 2 weeks of the study.
  • Use of NSAIDS or aspirin within 7 days of the study.
  • Use of immunosuppressants within 30 days of the study.
  • Family history (first degree relative) of Celiac Disease.
  • Received an investigational product within 1 month of study.
  • History of digestive enzyme deficiencies.
  • History of severe reactions to low doses of gluten/accidental exposure to gluten.
  • History of wheat allergy (positive reactions to the skin-prick test or the IgE blood test).
  • History of lactose, milk protein and/or FODMAP allergies.
  • Subjects who have an immune-compromised condition.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups, including a placebo group

Treatment (Probiotic ES1)
Experimental group
Description:
Capsules containing 1 billion CFU of B. longum ES1 per capsule. One capsule taken before and after consuming 2 slices of bread for 7 days.
Treatment:
Other: Probiotic ES1
Placebo
Placebo Comparator group
Description:
Capsules not containing the active ingredient B. longum ES1. One capsule taken before and after consuming 2 slices of bread for 7 days.
Treatment:
Other: Placebo

Trial contacts and locations

1

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Central trial contact

Makayla Tosh, BSc.

Data sourced from clinicaltrials.gov

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