Alcat Based Elimination Diet for the Treatment of Irritable Bowel Syndrome; a Randomized Double Blind Sham Control Trial
Condition: IBS - Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

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.
    

Detailed description: 
      Diet therapies for IBS are becoming an important part of the treatment for patients with IBS
      [Lenhart A et al, J Neurogastroenterology Motil 2018] There are many types of elimination
      diets utilized by patients with IBS including personalized diets based upon mediator release
      testing and IgG (immunoglobulin G) antibody. These diets have the potential for tailor made
      personal diet but currently have little or no clinical evidence for efficacy.

      Diet therapies, like medical therapies for IBS, should be properly evaluated in appropriate
      designed clinical trials.

      It is also important to protect our patients with IBS from potentially ineffective, costly
      and unsafe intervention.
    

Intervention name(s): Alcat based personal diet; Standard balanced diet; usual care
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Alcat based personalized diet with dietician supervision and follow-up + usual care; "Sham" standard balanced diet with dietician supervision and follow up + usual care.; usual care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind randomized clinical trial (RCT) comparing Alcat based personal diet for the treatment of IBS versus "sham" standard balanced diet
Masking: Double (Participant, Investigator)
Primary purpose: Treatment