Quality of Life in Diarrhea-predominant Irritable Bowel Syndrome Taking GABA

NCT06755489 | Completed

• 1 other identifier: GABA 2.0
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The study aims to evaluate the impact on quality of life and abdominal discomfort of GABA and Melissa food supplement administration in patients with diarrhea-predominant irritable bowel syndrome.

Conditions

Diarrhoea Predominant Irritable Bowel Syndrome

Keywords

gamma-aminobutyric acid; diarrhoea; abdominal pain; irritable bowel syndrome; GABA

Outcome Measures

Primary Outcomes (1)

• Quality of life

  Evaluation of quality of life in IBS-D patients taking GABA food supplement with Short-Form 36 Items Health Survey (SF-36 Italian version). A reduction at least of 10 points on at least 1 of the 8 subdomains of the SF36 score would be considered significant.

  From enrollment to the end of treatment at 12 weeks. Evaluated at every scheduled visit (V0, V1, V2, V3, FU)

Secondary Outcomes (5)

• Abdominal discomfort

  From enrollment to the end of treatment at 12 weeks. Evaluated at every scheduled visit (V0 (Week0), V1(Week 4), V2(Week 6), V3(week 10), FU(Week 12))

• Psychological impact

  From enrollment to the end of treatment at 12 weeks. Evaluated at every scheduled visit (V0, V1, V2, V3, FU)

• Intestinal microbiota

  From enrollment to the end of treatment at 10 weeks. Evaluated at every scheduled visit (V0, V1, V2, V3)

• Epithelial barrier impairment

  From enrollment to the end of treatment at 10 weeks. Evaluated at every scheduled visit (V0, V1, V2, V3)

• Systemic inflammation

  From enrollment to the end of treatment at 10 weeks. Evaluated at every scheduled visit (V0, V1, V2, V3)

Study Arms (2)

Group A

EXPERIMENTAL

Other: Placebo; Other: GABA

Group B

EXPERIMENTAL

Other: Placebo; Other: GABA

Interventions

Placebo OTHER

530 mg tablets containing microcrystalline cellulose, rice bran, bitter cocoa powder table 530 mg. 1 tablet three times a day

Group A; Group B

GABA OTHER

530 mg tablets containing Gamma-aminobutyric acid (GABA) and different bulking agent as microcrystalline cellulose, calcium carbonate, lemon balm d.e. Leaves (melissa officinalis l. - maltodextrin) tit. 2% in rosmarinic acid, anti-caking agents: silicon dioxide, vegetable magnesium stearate. 1 tablet three times a day

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years and ≤ 75
• A positive diagnosis of IBS-D according to Rome IV criteria.
• Both males and females.
• Negative relevant additional screening or consultation whenever appropriate
• Colonoscopy if there are alarm symptoms (eg. Rectal bleeding, pseudodiarrhea). If the patients' age is \> or = 50 yrs a colonoscopy within 5 years is mandatory.
• Availability to participate in the clinical study, confirmed by the signed informed consent form.
• Ability to conform to the study protocol.
• Patients' ability to complain study protocol procedures.
• Subjects who decide to use single or double contraceptive methods not to conceive during study period.

You may not qualify if:

• Patients with IBS-C, IBS-M and IBS-U according to Rome IV criteria.
• Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant.
• Ascertained intestinal organic diseases, including celiac disease, food allergies or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis).
• Previous major abdominal surgery.
• Active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable).
• Use of -pre or probiotics, topical and/or systemic antibiotic and prokinetic therapy during the 15 days before treatment starts.
• Systematic/frequent use of contact laxatives.
• Pregnant or breastfeeding woman.
• Females of childbearing potential in the absence of effective contraceptive methods.
• Inability to conform to protocol.
• Treatment with any investigational drug within the previous 30 days.
• Recent history or suspicion of alcohol abuse or drug addiction.
• Presence of red or white flags at the Rome IV Psychosocial Alarm Questionnaire for Functional gastrointestinal Disorders

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Pisana (AOUP): collaborator
• University of Pisa: lead

Study Sites (2)

Azienda Ospedaliero Universitaria Pisana

Pisa, 56124, Italy

Location

University of Pisa

Pisa, 56126, Italy

Location

Related Publications (9)

• Mearin F, Lacy BE, Chang L, Chey WD, Lembo AJ, Simren M, Spiller R. Bowel Disorders. Gastroenterology. 2016 Feb 18:S0016-5085(16)00222-5. doi: 10.1053/j.gastro.2016.02.031. Online ahead of print.

  PMID: 27144627 BACKGROUND

• Sokovic Bajic S, Djokic J, Dinic M, Veljovic K, Golic N, Mihajlovic S, Tolinacki M. GABA-Producing Natural Dairy Isolate From Artisanal Zlatar Cheese Attenuates Gut Inflammation and Strengthens Gut Epithelial Barrier in vitro. Front Microbiol. 2019 Mar 18;10:527. doi: 10.3389/fmicb.2019.00527. eCollection 2019.

  PMID: 30936860 BACKGROUND

• Gros M, Gros B, Mesonero JE, Latorre E. Neurotransmitter Dysfunction in Irritable Bowel Syndrome: Emerging Approaches for Management. J Clin Med. 2021 Jul 31;10(15):3429. doi: 10.3390/jcm10153429.

  PMID: 34362210 BACKGROUND

• Carabotti M, Scirocco A, Maselli MA, Severi C. The gut-brain axis: interactions between enteric microbiota, central and enteric nervous systems. Ann Gastroenterol. 2015 Apr-Jun;28(2):203-209.

  PMID: 25830558 BACKGROUND

• Cervero F. Central sensitization and visceral hypersensitivity: Facts and fictions. Scand J Pain. 2014 Apr 1;5(2):49-50. doi: 10.1016/j.sjpain.2014.02.005. No abstract available.

  PMID: 29913675 BACKGROUND

• Bellini M, Gambaccini D, Stasi C, Urbano MT, Marchi S, Usai-Satta P. Irritable bowel syndrome: a disease still searching for pathogenesis, diagnosis and therapy. World J Gastroenterol. 2014 Jul 21;20(27):8807-20. doi: 10.3748/wjg.v20.i27.8807.

  PMID: 25083055 BACKGROUND

• Portincasa P, Bonfrate L, de Bari O, Lembo A, Ballou S. Irritable bowel syndrome and diet. Gastroenterol Rep (Oxf). 2017 Feb;5(1):11-19. doi: 10.1093/gastro/gow047. Epub 2017 Jan 20.

  PMID: 28110300 BACKGROUND

• Minderhoud IM, Oldenburg B, Wismeijer JA, van Berge Henegouwen GP, Smout AJ. IBS-like symptoms in patients with inflammatory bowel disease in remission; relationships with quality of life and coping behavior. Dig Dis Sci. 2004 Mar;49(3):469-74. doi: 10.1023/b:ddas.0000020506.84248.f9.

  PMID: 15139501 BACKGROUND

• Morales-Soto W, Gulbransen BD. Enteric Glia: A New Player in Abdominal Pain. Cell Mol Gastroenterol Hepatol. 2019;7(2):433-445. doi: 10.1016/j.jcmgh.2018.11.005. Epub 2018 Nov 24.

  PMID: 30739868 BACKGROUND

MeSH Terms

Conditions

Diarrhea; Abdominal Pain; Irritable Bowel Syndrome

Interventions

gamma-Aminobutyric Acid

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor in gastroenterology

Model Details: Monocentric, randomized, double-blind, parallel group, placebo-controlled, cross-over study

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 1, 2025
• Study Start: April 17, 2023
• Primary Completion: November 19, 2024
• Study Completion: March 21, 2025
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)