Irritable Bowel Syndrome-Constipation Clinical Trial
Official title:
Randomized Controlled Trial of Treating Rectal Hypersensitivity - Comparing Escitalopram With Sensory Adaptation Training
| Verified date | August 2020 |
| Source | Augusta University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Constipation is a common digestive disorder. After excluding dietary factors, drugs and other
secondary causes, at least three broad pathophysiologic subtypes are recognized- dyssynergic
defecation, constipation-predominant irritable bowel syndrome (IBS-C) and slow transit
constipation (STC), all predominantly affect women and elderly. Many patients also
demonstrate abnormal rectal perception with both rectal hyposensitivity and hypersensitivity
being common. Recent surveys show that most constipated patients are dissatisfied with
current therapy. Also, constipated patients showed significant psychological dysfunction and
impaired quality of life. OBJECTIVE: To investigate a novel biofeedback technique of
improving rectal hypersensitivity.
METHODS: A large compliant balloon attached to a barostat was placed in the rectum in 8
patients with rectal hypersensitivity (urgency/pain threshold <30 mm Hg). Sensory
deconditioning was performed by incremental balloon distensions (1-2 mmHg) until normal
thresholds were reached.
| Status | Completed |
| Enrollment | 55 |
| Est. completion date | December 31, 2019 |
| Est. primary completion date | December 31, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: All patients must fulfill the diagnostic criteria for IBS-C (Rome III) as defined below and have rectal hypersensitivity (see below). - Patients must report recurrent abdominal pain or discomfort for at least 3 days per month in the last 3 months with two or more of the following symptoms: - Improvement with defecation; and/or - Onset associated with a change in frequency of stool; and/or - Onset associated with a change in form (appearance) of stool - No structural diseases - On a diary: - Pain/discomfort for at least 2 days/week; - No loose or watery stool <25% of bowel movements. Exclusion Criteria: - Patients with mixed-IBS. - Patients currently on SSRI or MAO inhibitors. Patients on stable doses of other antidepressants will be included provided the dose is unchanged during study. - Patients taking drugs that are constipating, (e.g.; calcium channel antagonists will either be excluded or drug discontinued) - Patients with co-morbid illnesses; severe cardiac disease, chronic renal failure or previous gastrointestinal surgery except cholecystectomy and appendectomy. - Neurologic diseases e.g.; head injury, epilepsy, multiple sclerosis, strokes, spinal cord injuries. - Impaired cognizance (mini mental score of < 15) and/or legally blind. - Pregnant or likely to conceive during the course of the study. Women with potential for pregnancy must be willing to use contraceptive measures during the study. Urinary pregnancy tests will be performed on such women prior to any radiologic procedures. - Hirschsprung's disease. - Alternating constipation and diarrhea (22). - Ulcerative/Crohns colitis. - Previous pelvic surgery, rectocele/bladder repair, radical hysterectomy, anal surgery. - Rectal prolapse or anal fissure. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Augusta University | Augusta | Georgia |
| United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
| Lead Sponsor | Collaborator |
|---|---|
| Augusta University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rectal Sensory Thresholds | The primary physiologic outcome measure is increase in rectal sensory thresholds after treatment. A rectal hypersensitivity responder is defined as an individual who show at least 20% increase in two or more sensory thresholds (first, desire and urge defecate/pain) after treatment when compared to baseline, and will be compared between the SAT and escitalopram groups. An overall responder is defined as both a hypersensitivity responder and abdominal pain responder. | Trial entry and at the end of 3 months | |
| Primary | Abdominal Pain | The symptomatic outcome measure is decrease in pain score as assessed by daily pain logs where pain is scored on a scale of 0 to 4, after treatment when compared to the baseline period. A pain responder is defined as a subject with 30% decrease in pain compared to baseline. | Trial entry and at the end of 3 months | |
| Secondary | Global Bowel Satisfaction Score (GSA) | The global bowel satisfaction will be analysed using a visual analog scale 0-10 cm (0 - very dissatisfied, 10 - completely satisfied). | Trial entry and at the end of 3 months | |
| Secondary | Bowel symptoms | We will assess the number of complete spontaneous bowel movements, mean straining scores, mean stool consistency (Bristol Stool Scale) (numerical mean scores for individual questions) between the two groups. | Trial entry and at the end of 3 months | |
| Secondary | Rectal compliance | We will assess the changes in intrarectal pressures and intrarectal volumes during Barostat rectal balloon distention between the two groups. | Trial entry and at the end of 3 months | |
| Secondary | IBS quality of life | The IBS quality of life will be assessed using the 8 domains of IBS-QOL and compared between the two groups. | Trial entry and at the end of 3 months | |
| Secondary | Psychological profiles | The psychological profiles will be assessed using the SCL-90R questionnaire and compared between the two groups. | Trial entry and at the end of 3 months |