Pain Relief In Irritable Bowel Syndrome

NCT02573844 | Completed Phase 4 DMC

• 1 other identifier: Geophyt
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether Proklama is effective in significative reduction of pain, other symptoms IBS's related, and improves quality of life concerning IBS disease.

Conditions

Irritable Bowel Syndrome

Keywords

irritable bowel syndrome; abdominal pain; rome III criteria; abdominal distension; consistency of stools; stool frequency; meteorism; flatulence; abdominal discomfort; proklama; probiotics; alga klamath; aphanizomenon flos-aquae; prebiotics; colitis ulcerosa

Outcome Measures

Primary Outcomes (1)

• Recorded pain in a diary using a 11-points Numeric Rating Scale (NRS)

  Self reported evaluation of the most severe pain occurred in the previous 24 hours. Pain severity is scored 0-10 ( 0= absent; 10= pain as bad as can be).

  24 h

Secondary Outcomes (15)

• Recorded abdominal distension in a diary using a 11-points Numeric Rating Scale (NRS)

  24 h

• Recorded abdominal discomfort in a diary using a 11-points Numeric Rating Scale (NRS)

  24 h

• Recorded abdominal meteorism in a diary using a 11-points Numeric Rating Scale (NRS)

  24 h

• Recorded flatulence in a diary using a 11-points Numeric Rating Scale (NRS)

  24 h

• Recorded borborygmi in a diary using a 11-points Numeric Rating Scale (NRS)

  24 h

Study Arms (2)

A: Proklama ( 1 sachet/ day)

ACTIVE COMPARATOR

15 patients belonging to group A will receive drug A (Proklama: 1 sachet/ day). The treatment will be administred starting from visit 3 for a 2 weeks- treatment's period. After a 2 weeks wash out's period, patients belonging to group A, starting from visit 5, will receive drug B ( Placebo: 1 sachet/day).

Drug: Proklama

B: Placebo ( 1 sachet/ day)

PLACEBO COMPARATOR

15 patients belonging to group B will receive drug B (Placebo: 1 sachet/ day). The treatment will be administred starting from visit 3 for a 2 weeks- treatment's period. After a 2 weeks wash out's period, patients belonging to group B, starting from visit 5, will receive drug A ( Proklama: 1 sachet/day).

Drug: Placebo

Interventions

Proklama DRUG

A: Proklama ( 1 sachet/ day)

Placebo DRUG

B: Placebo ( 1 sachet/ day)

Eligibility Criteria

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

You may qualify if:

• patients over 18 y.o.
• clinical diagnosis of IBS following Rome III symptom- based criteria:
• abdominal pain or discomfort recurring for at least 3 days a month in the previous 3 months, associated with 2 of the following characteristics at least: improved with evacuation; onset associated with variation of stool frequency; onset associated with changes in stool consistency
• onset of symptomatology at least 6 months preceding diagnosis
• additional criterion: mean severity of abdominal pain higher than 3 in the 11-points NRS
• For patients over 50 y.o. or with positive familiarity for colorectal cancer: normal colonoscopy performed within 5 years from the beginning of the screening's period and after symptomatology's onset
• For patients over 65 y.o. : absence of ischemic / microscopic colitis, or other organic gastrointestinal disorders, as highlighted through colonoscopy with biopsy performed within 6 months from the beginning of the screening's period
• For fertile and sexually active women: use of effective contraception with failure rate of less than 1% for one year during the trial period and 30 days after its end.
• Oral contraceptive are admitted as long as formulation didn't undergo changes during the 6 months preceeding the trial.
• Physical examination is negative during the period of screening
• Absence of significant alterations in 12- lead ECG during the period of screening.
• Normal haematochemical parameters during the period of screening
• Compliant patients towards procedures provided for the study, especially the use of daily diary
• Patients with mental integrity, able to express an informed before any procedure related to protocol, compliant toward clinical examinations provided for the protocol.
• Patients willing to avoid loperamide and laxatives use during the 3 days preceding run in and during the whole run in's period ( to be verified before randomization)

You may not qualify if:

• Male gender
• Patient has a diagnosis of IBS with a subtype of constipation, mixed IBS, or unsubtyped IBS according to the Rome III criteria
• Patient has had surgery that meets any of the following criteria:
• a) colonic or major abdominal surgery, i.e. bariatric surgery and stomach, small/ large bowel or large vessel abdominal surgery ( except appendicectomy, hysterectomy, cholecystectomy, caesarean section, or laparoscopic surgery).
• Patient has any elective major surgery planned or expected at any time during the study.
• Patient has a history of inflammation bowel diseases, complicated diverticulosis ( i.e. diverticulitis), ischaemic colitis, microscopic colitis.
• Patient has a history of organic abnormalities of the GI tract, intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, adhesions or impaired intestinal circulation ( e.g., aortoiliac disease).
• Patient has a history of pancreatitis of any etiology, cholecystitis or of symptomatic gallbladder stone disease in the previous 6 months.
• Patient has an active biliary duct disease of a history of Sphincter of Oddi dysfunction.
• Patient has a history of gluten enteropathy.
• Patient has a history of lactose intolerance as assessed by response to diet.
• Patient has a current or previous diagnosis of neoplasia ( except non-GI) neoplasia in complete remission \< or = 5 years, squamous and basal cell carcinomas and cervical carcinoma in situ).
• Patient has a history of ectopic endometriosis.
• Patient has a history of positive tests for ova or parasites, or clostridium difficile toxin or occult blood in the stool in the previous 6 months.
• Patient has a history of human immunodeficiency virus infection.

Sponsors & Collaborators

• Geophyt S.r.l.s.: lead

Study Sites (1)

Policlinico San Matteo Pavia Fondazione IRCCS

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Abdominal Pain; Flatulence; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 12, 2015
• Study Start: January 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: June 1, 2018
• Last Updated: August 9, 2021

Record last verified: 2021-08

Locations

IT (1)