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

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

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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