Colonic Motility Index, Constipation
Conditions
Brief summary
The research study is designed to test how a medication called octreotide affects the motility (contraction or squeezing) of the colon (large intestine). Investigators are investigating whether octreotide can increase contraction and movement in the colon.
Detailed description
As mentioned above.
Interventions
DRUGOctreotide
Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide
DRUGBisacodyl
Sponsors
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Male or female and undergoing colonic manometry for a routinely accepted indication including: evaluation of chronic constipation, unexplained abdominal distension (Should have had previous diagnostic work up), recurrent fecal impaction, post Hirschsprung's disease repair, chronic intestinal pseudo-obstruction, or suspected colonic dysmotility of any other cause. * Children aged 12 months or older who are undergoing colonic motility under the supervision of Dr. Joseph Croffie at Riley Hospital. * In the investigator's judgment, parent(s)/guardian(s) is mentally competent to provide informed consent to participate in the study.
Exclusion criteria
* • Subjects with known or suspected allergy to octreotide. * Subjects with known prolonged corrected QT interval (QTc) Syndrome or highest risk QTc-Prolonging Agents (including mifepristone). * Subjects with known history of ventricular arrhythmia. * Subjects with history of any organ transplant who are taking cyclosporine at the time of the motility study. * Subjects with history of small bowel transplant. * Subjects less than 12 months old. * Subjects with severe renal impairment * Subjects with severe hepatic impairment * Subjects taking bromocriptine, insulin, oral hypoglycemic agents, beta blockers, calcium channel blockers, quinidine, terfenadine, pimozide, sildenafil, tadalafil, and any agents to control fluid and electrolyte imbalance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compared Colonic Motility Index From Fasting to Post Octreotide Infusion | Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide. | Colonic motility was measured using a solid-state catheter. The catheter had 36 sensors spaced 5-cm apart for the first 15 sensors and 1-cm apart for the remaining sensors. Pressures were transmitted to a transducer and recorded on a personal computer system (Medical Measurement Systems USA, Dover, NH). Motility index (MI) was calculated using the Medical Measurement Systems computer program. The MI represents the area under the curve of the pressure tracing for a certain period (21). The MI was calculated for each channel. The MIs from all of the channels were then averaged to give each patient 1 average MI for the particular period under study. In this study, MI was calculated for the periods of 15, 30, and 45 minutes before and after infusion of octreotide. MI is reported as millimeters of mercury (mmHg) per 15, 30, or 45 minutes. |
Countries
United States
Participant flow
Recruitment details
All eligible patients referred for colonic manometry to the GI Motility Laboratory at Riley Hospital between Sep 2013 and June 2014. 24 patients were assessed for eligibility to participate in the study in the hospital. 8 patients were excluded, as they did not meet inclusion criteria. 3 participant refused enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Octreotide 1. Fasting motility was recorded for at least 60 minutes.
2. Octreotide 1mcg/kg, maximum of 50mcg was administered subcutaneously (one hour after application of EMLA topical cream). Motility was then recorded for 45-60 minutes.
3. Patients were then offered a high-fat, high-energy meal as described elsewhere, and motility was recorded for 60 minutes.
4. Patients then received 1 to 2 doses of bisacodyl (0.2 mg/kg, maximum of 10 mg) through the motility catheter, and motility was recorded. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Octreotide |
|---|---|
| Age, Continuous | 9.3 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Compared Colonic Motility Index From Fasting to Post Octreotide Infusion
Colonic motility was measured using a solid-state catheter. The catheter had 36 sensors spaced 5-cm apart for the first 15 sensors and 1-cm apart for the remaining sensors. Pressures were transmitted to a transducer and recorded on a personal computer system (Medical Measurement Systems USA, Dover, NH). Motility index (MI) was calculated using the Medical Measurement Systems computer program. The MI represents the area under the curve of the pressure tracing for a certain period (21). The MI was calculated for each channel. The MIs from all of the channels were then averaged to give each patient 1 average MI for the particular period under study. In this study, MI was calculated for the periods of 15, 30, and 45 minutes before and after infusion of octreotide. MI is reported as millimeters of mercury (mmHg) per 15, 30, or 45 minutes.
Time frame: Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| 15 Minutes | Compared Colonic Motility Index From Fasting to Post Octreotide Infusion | pre-octreotide | 6.03 mm Hg |
| 15 Minutes | Compared Colonic Motility Index From Fasting to Post Octreotide Infusion | post-octreotide | 5.32 mm Hg |
| 30 Minutes | Compared Colonic Motility Index From Fasting to Post Octreotide Infusion | post-octreotide | 6.71 mm Hg |
| 30 Minutes | Compared Colonic Motility Index From Fasting to Post Octreotide Infusion | pre-octreotide | 6.89 mm Hg |
| 45 Minutes | Compared Colonic Motility Index From Fasting to Post Octreotide Infusion | pre-octreotide | 7.73 mm Hg |
| 45 Minutes | Compared Colonic Motility Index From Fasting to Post Octreotide Infusion | post-octreotide | 7.53 mm Hg |
Comparison: The Wilcoxon signed rank test was used to analyze change in MI at 15 minutes. Values were considered to be significant if P \<0.05.p-value: 0.087Wilcoxon signed rank test
Comparison: The Wilcoxon signed rank test was used to analyze change in MI at 30 minutes. Values were considered to be significant if P \<0.05.p-value: 0.552Wilcoxon signed rank test
Comparison: The Wilcoxon signed rank test was used to analyze change in MI at 45 minutes. Values were considered to be significant if P \<0.05.p-value: 0.807Wilcoxon signed rank test