Describing movements of the large bowel in different bowel disorders in comparison to health and their role in moving bowel content

Phase 1

• Conditions: Functional bowel disorders; irritable bowel syndrome (constipation, diarrhea and mixed), chronic constipation, and chronic diarrhea.; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-002679-25-BE
• Lead Sponsor: KU Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-04
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

1. Patient is a man or woman aged 18 to 80 years, inclusive, at prescreening.
2. Patient has a diagnosis of a functional bowel disorder according to the Rome IV criteria.
3. Patient needs a colonoscopy for diagnostic reasons, for risk factors (age above 50 years of age), or because of occurrence of alarm features (weight loss within the past 6 months; family history of colorectal cancer or IBD; blood loss with their stool, not convincingly due to hemorrhoids or fissure).
4. Patient has not used any loperamide rescue medication within 2 days prior to randomization.
5. Patient has not used any opioid medication to reduce their pain within 14 days prior to randomization
6. Patients on stable doses of antidepressants (ie, for the 3 months prior to prescreening) will be allowed to participate in the study. Medications taken for the treatment of allergies, chronic medical conditions, and migraine headaches can be taken during this study (with the exception of opioids for acute treatment of migraines). Patient must be on a stable dose of medication for chronic migraines or preventative therapy for at least 1 month at prescreening. As needed use of benzodiazepines, if habitual, is permitted.
7. Female patients must be:
a. postmenopausal, defined as 52 years or older and amenorrheic for at least 2 years at prescreening,
b. surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
c. abstinent, or
d. if sexually active, be practicing an effective method of birth control such as hormonal prescription oral contraceptives, progesterone implants or injections, contraceptive patch, intrauterine device, or male partner with a vasectomy.
8. Patient must sign an informed consent document before the initiation of any study-related procedures indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of inflammatory or immune-mediated GI disorders including inflammatory bowel disease (ie, Crohn’s disease, ulcerative colitis) and celiac disease.
2. History of diverticulitis
3. History of intestinal obstruction, stricture, toxic megacolon, GI perforation, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease).
4. Patient has any of the following surgical history:
a. Any abdominal surgery within the 3 months prior to prescreening;
b. Patient has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post-surgery are allowed).
5. History or current evidence of laxative abuse.
6. Patient has a history of a cardiovascular event, including stroke, myocardial infarction, congestive heart failure, or transient ischemic attack within 6 months prior to prescreening.
7. Patient has an unstable renal, hepatic, metabolic, or hematologic condition.
8. Patient has a history of malignancy within 5 years before prescreening (except squamous and basal cell carcinomas and cervical carcinoma in situ).
9. Patient has abnormal thyroid function test as confirmed by thyroid-stimulating hormone <0.3 mcIU/mL or =5 mcIU/mL at Prescreening. However, patients who are clinically euthyroid due to thyroid supplement are candidates for the study.
10. Patient has current (within 14 days of randomization) or expected use of any narcotic or opioid containing agents, docusate, enemas, GI preparations (including antacids containing aluminum or magnesium, antidiarrheal agents, antinausea agents, antispasmodic agents, bismuth, or prokinetic agents).
11. Patient is pregnant or breastfeeding.
12. Patient has any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified