Alcat Based Elimination Diet for the Treatment of Irritable Bowel Syndrome; a Randomized Double Blind Sham Control Trial

NCT05616429 | Completed

• 1 other identifier: 6834-20-TA-CTIL
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable bowel syndrome (IBS) is the most common GI condition with global prevalence ranging between 10-20%. Although the exact cause is not known there are increasing insights concerning the possible multifactorial etiology including low grade inflammation, neuromodulation, dysbiosis, impaired integrity of the intestinal barrier and more. Currently, it is believed that changes in the microbiota may activate mucosal innate immune responses, resulting in increased epithelial permeability, activated nociceptive sensory pathways, and dysregulation of the enteric nervous system. Nearly two thirds of patients with IBS perceive their GI symptoms to be food related, hence, food intolerance may be important factor in the pathogenesis. Diet is a part of IBS treatment but adherence, on the one hand, and restriction, on the other, remain a major problem. \[Chey WD, Am J Gastroenterol,2016\]. Confocal laser endomicroscopy (CLE) is a technique that permits real-time detection and quantification of changes in intestinal tissues and cells, including increases in intraepithelial lymphocytes and fluid extravasation through epithelial leaks. Based on CLE analysis of IBS patients with a suspected food intolerance, exposure to candidate food antigens caused immediate breaks, increased intervillous spaces, and increased IELs in the intestinal mucosa. These changes are associated with patient responses to exclusion diets. \[Fritscher-Ravens A et al, Gastroenterology. 2019, Gastroenterology. 2014\] This technic, also efficient according to former studies, is costly and invasive. The Alcat Test is a lab based immune stimulation test in which a patient's WBC's (white blood cell) are challenged with various substances including foods, additives, colorings, chemicals, medicinal herbs, functional foods, molds and pharmaceutical compounds. The Alcat Test objectively classifies a patient's response to each test substance as reactive, borderline or non-reactive. Based on these classifications, a customized elimination/rotation diet may be designed.

Conditions

IBS - Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Irritable Bowel Syndrome (IBS) Symptom Severity Scale questionnaire

  decrease of 50 points. Values range: 0-500

  8 weeks

Secondary Outcomes (6)

• Irritable Bowel Syndrome Global Symptom Assessment (IBS-GSA) questionnaire

  4 and 8 weeks

• Abnormal laboratory value - bio marker

  8 weeks

• Monitoring serum level of Syndecan-1 (Sdc1) ng/mL

  8 weeks

• Irritable Bowel Syndrome (IBS) Adequate Relief questionnaire

  up to 8 weeks

• Irritable Bowel Syndrome Quality of life questionnaire - specific for IBS (IBS-QoL)

  8 weeks

Study Arms (2)

Alcat based personal diet

EXPERIMENTAL

Dietary Supplement: Alcat based personal diet; Other: usual care

Standard balanced diet

SHAM COMPARATOR

Dietary Supplement: Standard balanced diet; Other: usual care

Interventions

Alcat based personal diet DIETARY_SUPPLEMENT

Alcat based personalized diet with dietician supervision and follow-up + usual care

Alcat based personal diet

Standard balanced diet DIETARY_SUPPLEMENT

"Sham" standard balanced diet with dietician supervision and follow up + usual care.

Standard balanced diet

usual care OTHER

usual care

Alcat based personal diet; Standard balanced diet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Only adults (\>18 years of age) meeting the Rome 4 Criteria for IBS D/M/U and who are willing to adhere to diet restrictions, will be eligible for entry into the study.
• Patients with 'warning symptoms' (e.g., unexplained weight loss, history of GI cancer or inflammatory bowel disease, rectal bleeding etc) will be required to have had a detailed workup to exclude organic pathology prior to enrollment.
• Participants will be allowed to continue their IBS medications (e.g., fiber, anti-spasmodics, antidepressants, loperamide, etc.) as long as they had been on stable doses for at least 30 days prior to entering the study and agreed not to change medications or dosages during the trial.
• In addition, patients will be required to have active symptoms at the entry of the study as defined by having an IBSSSS score of \>150 (0-500 scale).

You may not qualify if:

• Patients will be excluded if they fulfill ROME 4 IBS C criteria
• Have an inflammatory bowel disease, celiac or other inflammatory or gut disorder other than IBS.
• Have active malignancy of any kind
• If they are not able to eat PO
• If C reactive protein is above 2 times the normal value or if stool Calprotectin is above 200mcg/gr
• If they had recent antibiotic use (within 1 month). -

Sponsors & Collaborators

• Sheba Medical Center: lead
• Cell science systems: collaborator

Study Sites (1)

Sheba Medical Center

Ramat Gan, 5262000, Israel

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double blind randomized clinical trial (RCT) comparing Alcat based personal diet for the treatment of IBS versus "sham" standard balanced diet

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 15, 2022
• Study Start: August 1, 2020
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)