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Completed

NCT Number: NCT01412372

The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study

The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma cytokines before and after treatment with Lialda.

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Key information

Conditions

Irritable Bowel Syndrome Abdominal Pain Colonic Diseases Colonic Diseases, Functional Diarrhea Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Hypersensitivity Immune System Diseases Intestinal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Utah

Salt Lake City, Utah, 84132, United States

About this study

This study will test long acting mesalamine in the management of PI-IBS. It has the potential to improve QOL and perhaps gastrointestinal symptoms, in patients with PI-IBS. The results of this study, if positive, will provide preliminary data for a large scale clinical trial.

This study will also provide information about plasma cytokines in patients with PI-IBS and whether improvement in symptoms correlates with improvement in plasma cytokines.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

  • Men and women age 18-75 years
  • Rome III criteria for IBS
  • Symptom onset after apparent acute gastroenteritis
  • Symptoms of 6 months or greater duration
  • Normal gross appearance of the colonic mucosa other than erythema
  • Negative markers for celiac disease and inflammatory bowel disease
  • Normal thyroid function and serum calcium
  • Stable medication regimens for other medical conditions.

Exclusion criteria

  • Age <18 or >75 years
  • Previous diagnosis of or history compatible with IBS
  • Constipation-predominant IBS.
  • Clinically significant chronic cardiac, pulmonary, hepatic, renal dysfunction or HIV
  • History of/or presence of malignancy
  • Current evidence of any gastrointestinal disorder such as celiac disease, inflammatory bowel disease, chronic pancreatitis, scleroderma, HIV, small bowel or colonic resection, paraplegia or quadriplegia. .
  • Current evidence of drug or alcohol abuse as judged by the investigator
  • Allergy to mesalamine or aspirin
  • Investigator perception of patient's inability to comply with the study protocol
  • Unstable psychiatric disease
  • Recent change in gastrointestinal medications

Treatment and study plan

Mesalamine

Drug

2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo

Other names: Lialda

Placebo

Drug

This is an inactive pill

Other names: Inactive drug

Primary outcomes

  1. Change in Average Overall Bowel Symptom Score (BSS) After an 8 Week Treatment Period

    Time frame: Baseline and 8 weeks

    BSS score measured from sum of BSS items of abdominal pain severity, bloating severity, diarrhea severity, constipation severity, and how satisfied are you with bowel habits, and measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe.

Secondary outcomes

  1. Change in Average Overall IBS Specific Quality of Life Score After an 8 Week Treatment Period.

    Time frame: Baseline and 8 weeks

    As measured by the IBS specific Quality of Life questionnaire which consists of 34 items scored on a scale of 0% to 100%, 0 being not at all and 100 being extremely.

  2. Change in Average Bowel Frequency After 8-Week Treatment Period

    Time frame: Baseline and 8 weeks

    Measured by the participant reported average number of daily bowel movements.

  3. Change in Average Bowel Consistency Score After an 8 Week Treatment Period.

    Time frame: Baseline and 8 weeks

    Measured using the Bristol Stool form scale 1-7, with 1 being the most formed and 7 the least formed.

  4. Change in Average Abdominal Pain Score After an 8 Week Treatment Period

    Time frame: Baseline and 8 weeks

    Measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe.

  5. Change in Average Bloating Score After an 8 Week Treatment Period.

    Time frame: Baseline and 8 weeks

    Measured on a scale of 0% to 100%, 0 being not severe and 100 being very severe.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Shire Human Genetic Therapies, Inc.

Registry information

Acronym: Mesalamine

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Aug 9, 2011
Registry last updated
Dec 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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