Trial · NCT01839734
Lubiprostone as a Modulator of Gut Microbial Translocation in HIV With Incomplete CD4 Recovery on Antiretroviral Therapy
NCT01839734, Phase 2, Completed, Ruth M. Rothstein CORE Center; results first posted 2023-08-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lubiprostone as a Modulator of Gut Microbial Translocation in HIV With Incomplete CD4 Recovery on Antiretroviral Therapy. Trials, record NCT01839734. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01839734
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lubiprostone as a Modulator of Gut Microbial Translocation in HIV With Incomplete CD4 Recovery on Antiretroviral Therapy
- NCT number
- NCT01839734
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Ruth M. Rothstein CORE Center
- Conditions
- HIV
- Interventions
- Lubiprostone
- First posted
- 2013-04-25
- Last updated
- 2023-08-30
- Results first posted
- 2023-08-30
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Gut Microbial Translocation (iFABP) | Baseline and 4 weeks | Summary difference of participant's median iFABP MT marker change at week 4 from baseline aggregate median values |
| Primary | Changes in Gut Microbial Translocation (Zonulin) | Baseline and 4 weeks | Summary difference of participant's median Zonulin MT marker change at week 4 from baseline aggregate median values. |
| Primary | Changes in Gut Microbial Translocation (sCD14) | Baseline and 4 weeks | Summary difference of participant's median sCD14 MT marker change at week 4 from baseline aggregate median values |
| Primary | Changes in Gut Microbial Translocation (sCD163) | Baseline and 4 weeks | Summary difference of participant's median sCD163 MT marker change at week 4 from baseline aggregate median values |
| Secondary | Changes in Systemic Inflammation (IL-6) | Baseline and 4 weeks | Summary difference of participant's median IL-6 inflammation marker change at week 4 from baseline aggregate median values. |
| Secondary | Changes in Systemic Inflammation (hsCRP) | Baseline and 4 weeks | Summary difference of participant's median hsCRP inflammation marker change at week 4 from baseline aggregate median values |
| Secondary | Changes in Peripheral CD4+ | Baseline and 4 weeks | Summary difference of participant's median CD4+ change at week 4 from baseline aggregate median values |
| Secondary | Number of Participants With Adverse Events During Study Period | 4 weeks | Safety monitoring, defined as Grade ≥ 2 signs and symptoms, Grade ≥ 2 laboratory abnormalities, and other serious adverse events (SAEs) not otherwise specified. |
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 | Changes in Gut Microbial Translocation (iFABP) | Baseline and 4 weeks | pg/mL | MEDIAN | |
| PRIMARY | Changes in Gut Microbial Translocation (Zonulin) | Baseline and 4 weeks | ng/ML | MEDIAN | |
| PRIMARY | Changes in Gut Microbial Translocation (sCD14) | Baseline and 4 weeks | pg/mL | MEDIAN | |
| PRIMARY | Changes in Gut Microbial Translocation (sCD163) | Baseline and 4 weeks | pg/mL | MEDIAN | |
| SECONDARY | Changes in Systemic Inflammation (IL-6) | Baseline and 4 weeks | pg/mL | MEDIAN | |
| SECONDARY | Changes in Systemic Inflammation (hsCRP) | Baseline and 4 weeks | pg/mL | MEDIAN | |
| SECONDARY | Changes in Peripheral CD4+ | Baseline and 4 weeks | cells/mm^3 | MEDIAN | |
| SECONDARY | Number of Participants With Adverse Events During Study Period | 4 weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in Gut Microbial Translocation (iFABP) | Lubiprostone | iFABP Baseline | 145.76 | Inter-Quartile Range 118.14 to 169.35 | pg/mL |
| Changes in Gut Microbial Translocation (iFABP) | Control | iFABP Baseline | 125.36 | Inter-Quartile Range 82.43 to 267.76 | pg/mL |
| Changes in Gut Microbial Translocation (iFABP) | Lubiprostone | iFABP Week 4 | 151.5 | Inter-Quartile Range 75.86 to 206.63 | pg/mL |
| Changes in Gut Microbial Translocation (iFABP) | Control | iFABP Week 4 | 111.73 | Inter-Quartile Range 98.44 to 139.84 | pg/mL |
| Changes in Gut Microbial Translocation (iFABP) | Lubiprostone | iFABP 4 Week summary difference | -9.34 | Inter-Quartile Range -74.32 to 71.74 | pg/mL |
| Changes in Gut Microbial Translocation (iFABP) | Control | iFABP 4 Week summary difference | 14.47 | Inter-Quartile Range -155.83 to 43.93 | pg/mL |
| Changes in Gut Microbial Translocation (Zonulin) | Lubiprostone | Zonulin Baseline | 1 | Inter-Quartile Range 0.95 to 1.11 | ng/ML |
| Changes in Gut Microbial Translocation (Zonulin) | Control | Zonulin Baseline | 3.24 | Inter-Quartile Range 1.46 to 7.14 | ng/ML |
| Changes in Gut Microbial Translocation (Zonulin) | Lubiprostone | Zonulin Week 4 | 1.06 | Inter-Quartile Range 0.83 to 1.88 | ng/ML |
| Changes in Gut Microbial Translocation (Zonulin) | Control | Zonulin Week 4 | 0.98 | Inter-Quartile Range 0.77 to 2.04 | ng/ML |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A | 16 | |
| Overall Study | STARTED | Arm B | 4 | |
| Overall Study | COMPLETED | Arm A | 16 | |
| Overall Study | COMPLETED | Arm B | 4 | |
| Overall Study | NOT COMPLETED | Arm A | 0 | |
| Overall Study | NOT COMPLETED | Arm B | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | Other adverse events | Gastrointestinal disorders | Lubiprostone | 8 | 16 | 8 |
| other | Other adverse events | Gastrointestinal disorders | No Intervention | 0 | 4 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lubiprostone | ||
| Total, all-cause mortality | No Intervention | ||
| Total, other adverse events | Lubiprostone | 8 | 16 |
| Total, other adverse events | No Intervention | 0 | 4 |
| Total, serious adverse events | Lubiprostone | 0 | 16 |
| Total, serious adverse events | No Intervention | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lubiprostone vs Control: Number of Participants With Adverse Events During Study Period | Trial comparisons |
| Lubiprostone vs No Intervention: serious adverse events | Trial comparisons |
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/NCT01839734
GET https://conductscience.org/api/trials/v1/NCT01839734/results?page=2