Trial · NCT02850276
Autonomic Neuropathy, GI Motility, and Inflammation in HIV
NCT02850276, Early phase 1, Completed, Icahn School of Medicine at Mount Sinai; results first posted 2019-05-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Autonomic Neuropathy, GI Motility, and Inflammation in HIV. Trials, record NCT02850276. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02850276
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Autonomic Neuropathy, GI Motility, and Inflammation in HIV
- NCT number
- NCT02850276
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 76 participants, actual
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Conditions
- HIV Disease
- Interventions
- Pyridostigmine
- First posted
- 2016-07-29
- Last updated
- 2019-05-29
- Results first posted
- 2019-05-29
- Limitations and caveats
- Limitations include difficulty with recruitment resulting in small sample size, and lack of placebo control.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Breath Test | baseline and week 8 | Breath Test at week 8 as compared to baseline. Breath test results is the rise in the combined hydrogen and methane during the breath test. |
| Primary | Number of Participants With Reduction in Small Intestinal Bacterial Overgrowth (SIBO) | week 8 | Number of participants with reduction in Small intestinal bacterial overgrowth (SIBO) assessed with breath testing after 8 weeks of treatment. The hydrogen breath test for the detection of small intestinal bacterial overgrowth (SIBO), obtained by having participants exhale into a plastic bag. the hydrogen content of the samples is measured using a commercially available analyzer. |
| Secondary | Mean Percent Retention of Gastric Contents on Gastric Emptying Study | Baseline and week 8 | Percent retention of gastric contents on gastric emptying study. GI dysmotility calculated from gastric emptying scintigraphy - measurement of the percent retention of gastric contents at 4 hours. |
| Secondary | Change in sCD14 Level | Baseline and week 8 | Change in sCD14 level at week 8 as compared to baseline. sCD14 is a marker of macrophage activation commonly used as an indirect measure of translocation |
| Secondary | Change in TNFα Level | Baseline and week 8 | TNFα is a pro-inflammatory cytokine which is induced by components of translocating bacteria. Change in TNFα level at week 8 compared to baseline |
| Secondary | Change in IL-6 Plasma Level | Baseline and week 8 | Change in IL-6 plasma level at week 8 as compared to baseline. Plasma interleukin-6 (IL-6), an important inflammatory mediator which predicts mortality in HIV as well as multiple medical co-morbidities, presumably via inflammatory mechanisms. |
| Secondary | The Composite Autonomic Symptom Score (COMPASS) | Baseline and week 8 | The gastrointestinal domain domain score of the COMPASS contains 12 items which reflect gastrointestinal symptoms of autonomic function. It is scored on a total scale of 0-28, with higher numbers reflecting worse symptoms. |
| Secondary | Medical Outcomes Study Questionnaire | Baseline and week 8 | Medical Outcomes Study (MOS-HIV) quality of life questionnaire. It is a 35 item questionnaire covering 11 dimensions of health including physical functioning, role functioning, pain, social functioning, emotional well-being, energy/fatigue, cognitive functioning, general health, health distress, overall QOL, and health transition. The total scale ranges from 0-100 with a higher score representing better functioning and well-being. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Breath Test | baseline and week 8 | ppm | MEDIAN | |
| PRIMARY | Number of Participants With Reduction in Small Intestinal Bacterial Overgrowth (SIBO) | week 8 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mean Percent Retention of Gastric Contents on Gastric Emptying Study | Baseline and week 8 | percent retention of gastric contents | MEAN | |
| SECONDARY | Change in sCD14 Level | Baseline and week 8 | mean florescence intensity | MEDIAN | |
| SECONDARY | Change in TNFα Level | Baseline and week 8 | mean florescence intensity | MEDIAN | |
| SECONDARY | Change in IL-6 Plasma Level | Baseline and week 8 | mean florescence intensity | MEDIAN | |
| SECONDARY | The Composite Autonomic Symptom Score (COMPASS) | Baseline and week 8 | score on a scale | MEAN | |
| SECONDARY | Medical Outcomes Study Questionnaire | Baseline and week 8 | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Breath Test | Pyridostigmine | Baseline | 28 | Inter-Quartile Range 14 to 50 | ppm |
| Change in Breath Test | Pyridostigmine | week 8 | 14 | Inter-Quartile Range 9 to 31 | ppm |
| Number of Participants With Reduction in Small Intestinal Bacterial Overgrowth (SIBO) | Pyridostigmine | 13 | Participants | ||
| Mean Percent Retention of Gastric Contents on Gastric Emptying Study | Pyridostigmine | Baseline | 3 | Inter-Quartile Range 2 to 4 | percent retention of gastric contents |
| Mean Percent Retention of Gastric Contents on Gastric Emptying Study | Pyridostigmine | week 8 | 2 | Inter-Quartile Range 2 to 4 | percent retention of gastric contents |
| Change in sCD14 Level | Pyridostigmine | Baseline | 2573 | Inter-Quartile Range 1859 to 3063 | mean florescence intensity |
| Change in sCD14 Level | Pyridostigmine | Week 8 | 2095 | Inter-Quartile Range 1784 to 2584 | mean florescence intensity |
| Change in TNFα Level | Pyridostigmine | Baseline | 134.0 | Full Range 114 to 152 | mean florescence intensity |
| Change in TNFα Level | Pyridostigmine | week 8 | 117.5 | Full Range 108 to 136 | mean florescence intensity |
| Change in IL-6 Plasma Level | Pyridostigmine | Baseline | 30.5 | Inter-Quartile Range 25 to 36 | mean florescence intensity |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pyridostigmine | 76 | |
| Overall Study | COMPLETED | Pyridostigmine | 15 | |
| Overall Study | NOT COMPLETED | Pyridostigmine | 61 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Stomach Cramps | Gastrointestinal disorders | Pyridostigmine | 1 | 15 | |
| other | Diarrhea | Gastrointestinal disorders | Pyridostigmine | 3 | 15 | |
| other | Flatulence | Gastrointestinal disorders | Pyridostigmine | 1 | 15 | |
| other | Dizziness | General disorders | Pyridostigmine | 1 | 15 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pyridostigmine | 0 | 15 |
| Total, other adverse events | Pyridostigmine | 5 | 15 |
| Total, serious adverse events | Pyridostigmine | 0 | 15 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21DK105917 | Autonomic neuropathy, gastrointestinal motility, and inflammation in HIV | ROBINSON-PAPP, JESSICA | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2015 to 2016 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02850276
GET https://conductscience.org/api/trials/v1/NCT02850276/registered