Constipation
Conditions
Keywords
Constipation, small intestinal bacterial overgrowth, stool bacteria
Brief summary
Patients with constipation often have bloating and abdominal distension. It is unclear if this is related to intestinal bacteria. Hypothesis: treatment for constipation may reduce small bowel and colon bacteria colonization, a change in the balance of stool microorganisms, and improve the symptoms of dyspepsia and constipation.
Detailed description
This is an open-label study to collect data on upper and lower GI symptoms, hydrogen breath test, stool PCR, and serum before and after 4 weeks of lubiprostone 24 mcg by mouth twice a day for 4 weeks.
Interventions
DRUGLubiprostone
24 mcg bid for 28 days
Sponsors
Takeda
University of Louisville
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Functional constipation by Rome III criteria
Exclusion criteria
1. History of esophageal or gastric surgery (including vagotomy, antireflux, and obesity surgery) 2. History of small bowel or colon resection (excluding appendectomy and cholecystectomy) 3. History of gastric outlet, small bowel, or colon obstruction 4. History of surgery for small bowel adhesion lysis 5. History of surgery for gastroparesis 6. Diagnosis of diabetes requiring daily medications 7. Diagnosis of connective tissue d/o (including scleroderma, lupus, mixed connective tissue disorder) 8. Diagnosis of neuromuscular disorder (including multiple sclerosis, Parkinson, muscular dystrophy, dysautonomia, dystonia) 9. Disorders of small bowel pseudo-obstruction or dumping syndrome 10. Untreated or poorly controlled hypothyroidism 11. Taking an opiate medication daily 12. Taking a medication daily that can cause constipation (calcium channel blocker, anticholinergic, iron supplements, etc.) 13. Active cancer being treated 14. History of significant liver, kidney, cardiac disease that may interfere with study compliance 15. Known allergy or side effects to lubiprostone 16. Non-ambulatory patients: bed-ridden, nursing home resident, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Small Intestinal Bacterial Overgrowth | 28 days | Percent of patients with bacterial overgrowth before and after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Small Bowel and Colon Transit Time by SmartPill® Transit Study | 28 days | — |
| Small Intestinal Bacterial Overgrowth (SIBO) | 28 days | SIBO was measured before and after treatment. |
Countries
United States
Participant flow
Recruitment details
Subjects recruited from outpatient clinics and advertisement
Pre-assignment details
Study consisted of a 4-week run-in period to wash out prior therapy for constipation. Subjects may withdraw if they can not stay off their medications for constipation.
Participants by arm
| Arm | Count |
|---|---|
| Lubiprostone Open Label | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Lubiprostone Open Label |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Age, Continuous | 52 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 1 / 25 |
Outcome results
Primary
Presence of Small Intestinal Bacterial Overgrowth
Percent of patients with bacterial overgrowth before and after treatment.
Time frame: 28 days
Population: ITT
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Before Open Label Lubiprostone | Presence of Small Intestinal Bacterial Overgrowth | 8 Participants |
| After Open Label Treatment | Presence of Small Intestinal Bacterial Overgrowth | 9 Participants |
p-value: 0.75t-test, 2 sided
Secondary
Small Bowel and Colon Transit Time by SmartPill® Transit Study
Time frame: 28 days
Population: We were unable to obtain the smart pills for this section of the protocol.
Secondary
Small Intestinal Bacterial Overgrowth (SIBO)
SIBO was measured before and after treatment.
Time frame: 28 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Before Open Label Lubiprostone | Small Intestinal Bacterial Overgrowth (SIBO) | 8 participants |
| After Open Label Treatment | Small Intestinal Bacterial Overgrowth (SIBO) | 9 participants |
p-value: 0.9Wilcoxon (Mann-Whitney)