Safety and Efficacy Study of PEA and Polydatin on Intestinal Inflammation and Visceral Hyperalgesia in IBS Patients

NCT01370720 | Unknown Phase 2

• 1 other identifier: CM&D Pharma Limited
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the pathophysiology of IBS remains largely unsettled, several mechanisms have been proposed to explain symptom generation. These include psychosocial factors, altered gastrointestinal motor function and altered perception of visceral stimuli because of chronic low-grade inflammation and increased nociceptive mediator release by inflammatory cells, particularly mast cells. The aim of this pilot study is to provide evidence of:

1. 1.intestinal mast cell (MC) infiltration and activation in IBS patients;
2. 2.down-modulation of MC activation by the oral administration of the association of palmitoylethanolamide (PEA) and polydatin in IBS patients.

Conditions

Irritable Bowel Syndrome

Keywords

IBS; mast cell activation; low grade inflammation; visceral hyperalgesia

Outcome Measures

Primary Outcomes (1)

• Changes from screening visit of mast cell infiltration and activation in biopsy samples of colon mucosa from IBS patients, following 12 weeks of dietary supplementation with palmitoylethanolamide (PEA) and polydatin

  Comparison between healthy volunteers and IBS patients (screening visit) on the following parameters: * number of infiltrating mast cells (ICH) * mast cell activation, as per histamine and tryptase release in the surnatant of cultured colon biopsy samples Comparison between active and placebo supplemented IBS patients (after 12 weeks from randomization) on the following parameters: * number of infiltrating mast cells (ICH) * mast cell activation, as per histamine and tryptase release in the surnatant of cultured colon biopsy samples

  screening visit and after 12 weeks

Secondary Outcomes (3)

• Changes in biomarkers related to the endocannabinoid system

  12 weeks after randomization

• Changes from screening visit of other inflammatory cell subsets in biopsy samples of colon mucosa from IBS patients, following 12 weeks of dietary supplementation with palmitoylethanolamide (PEA) and polydatin

  screening visit and after 12 weeks

• Safety assessment by no changes in laboratory parameters and vital signs

  4, 8, 12 weeks after randomization

Study Arms (2)

Recoclix (CM&D Pharma Limited)

ACTIVE COMPARATOR

Recoclix: two tablets per day for 12 weeks

Dietary Supplement: Recoclix

Placebo

PLACEBO COMPARATOR

IBS patients

Other: Placebo

Interventions

Recoclix DIETARY_SUPPLEMENT

tablets; 200 mg PEA+20 mg polydatin; 2 tablets/day; 12 weeks

Recoclix (CM&D Pharma Limited)

Placebo OTHER

tablets, 2tablets/day, 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• IBS patients (both males and females) with positive diagnosis based on Rome III criteria (all IBS subtypes will be included)
• Age in the range 18-70 years
• Subjects capable of conforming to the study protocol
• Subjects who have given their free and informed consent

You may not qualify if:

• Any relevant organic, systemic or metabolic disease, such as celiac disease, IDDM (Insulin-Dependant Diabetes Mellitus), Insulin-Independent Diabetes Mellitus, metabolic syndrome, pelvic organ prolapse, and urinary incontinence.
• Subjects with ascertained intestinal organic diseases (ulcerative colitis, Crohn's disease, microscopic colitis, infectious colitis, ischemic colitis, complicated diverticular disease).
• Subjects with untreated food intolerance, i.e. remaining symptomatic despite the withdrawal of the suspected food
• Previous major abdominal surgeries
• Females of childbearing potential, in the absence of effective contraceptive methods
• Subjects who become unable to conform to protocol
• Subjects who are continuously taking contact laxatives
• Subjects who have been continuously administered glucocorticoids, anti-histaminergic and mast cell stabilizer drugs within the previous 30 days
• Subjects who have been continuously administered trimebutine within the previous 30 days
• Treatment with any investigational drug within the previous 30 days
• Recent history or suspicion of alcohol abuse or drug addiction

Sponsors & Collaborators

• MARIA CRISTINA COMELLI: lead

Study Sites (1)

Dept Internal Medicine and Gastroenterology, Policlinico Sant'Orsola-Malpighi

Bologna, I-40138, Italy

RECRUITING

Related Publications (1)

• Cremon C, Stanghellini V, Barbaro MR, Cogliandro RF, Bellacosa L, Santos J, Vicario M, Pigrau M, Alonso Cotoner C, Lobo B, Azpiroz F, Bruley des Varannes S, Neunlist M, DeFilippis D, Iuvone T, Petrosino S, Di Marzo V, Barbara G. Randomised clinical trial: the analgesic properties of dietary supplementation with palmitoylethanolamide and polydatin in irritable bowel syndrome. Aliment Pharmacol Ther. 2017 Apr;45(7):909-922. doi: 10.1111/apt.13958. Epub 2017 Feb 6.

  PMID: 28164346 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

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

Central Study Contacts

VINCENZO STANGHELLINI, MD

CONTACT

+39 051 6364; Prof. Vincenzo Stanghellini <v.stanghellini@unibo.it>

ROSANNA COGLIANDRO, MD

CONTACT

+39 051 6364; rosanna.cogliandro@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head,R&D

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 10, 2011
• Study Start: February 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: June 19, 2012

Record last verified: 2012-06

Locations

IT (1)