Trial · NCT04458129
Polyethylene Glycol and Intestinal Inflammation in Cystic Fibrosis
NCT04458129, Phase 2, Terminated, University Hospital, Bordeaux
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Polyethylene Glycol and Intestinal Inflammation in Cystic Fibrosis. Trials, record NCT04458129. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04458129
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Polyethylene Glycol and Intestinal Inflammation in Cystic Fibrosis
- NCT number
- NCT04458129
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- University Hospital, Bordeaux
- Conditions
- Cystic Fibrosis
- Interventions
- Treatment with polyethylene glycol (Macrogol 4000)
- First posted
- 2020-07-07
- Last updated
- 2026-06-22
- Other registries' IDs
- eudract:2019-004958-29
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Impact of a 3-month polyethylene glycol treatment on intestinal inflammation assessed by measurement of fecal calprotectin (µg / g) by an ELISA biological test | 3 months after the inclusion visit i.e. 3 months after the initiation of treatment with polyethylene glycol | proportion of patients with fecal calprotectin \<250 µg / g measured by an ELISA test 3 months after initiation of treatment with polyethylene glycol, testifying to the absence of intestinal inflammation or slight inflammation. |
| Secondary | Evolution of the digestive inflammatory response, assessed by measurement of fecal calprotectin (µg / g) | Change from Baseline fecal calprotectin measurement at 3 months | Evolution of the digestive inflammatory response, assessed by measurement of fecal calprotectin (µg / g) by an ELISA biological test between the initiation of treatment (D0) and 3 months of treatment with polyethylene glycol (M3) |
| Secondary | Evolution of the digestive inflammatory response, assessed by Analysis of the expression of genes involved in the inflammatory and pro-oncogenic response | Change from Baseline measurement at 3 months | Analysis of the expression of genes involved in the inflammatory and pro-oncogenic response, using NanoString Technology and the nCounters® PanCancer Immune Profiling Panel |
| Secondary | Evolution of the digestive symptoms, assessed by the JenAbdomen CF-score | Change from Baseline measurement at 3 months | The JenAbdomen CF-score has been described in the following publication Tabori H. et al. Abdominal symptoms in cystic fibrosis and their relation to genotype, history, clinical and laboratory findings. PloS One 12,e0174463 (2017). the JenAbdomen CF-Score is based on a CF patient-reported outcome measure (PROM) that includes all relevant gastrointestinal symptoms and their impact on subjective quality of life |
| Secondary | Evolution of the quality of life scores, assessed by the CFQ-R questionnaire | Change from Baseline measurement at 3 months | The CFQ-R questionnaire has been described in the following publication: Modi, A. C. \& Quittner, A. L. Validation of a disease-specific measure of health-related quality of life for children with cystic fibrosis. J. Pediatr. Psychol. 28, 535-545 (2003). The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a disease-specific health-related quality of life (HRQOL) measure for children, adolescents and adults with cystic fibrosis (CF). It is a profile measure of HRQOL with several different domains. It has undergone extensive reliability and validity testing. The Cystic Fibrosis Questionnaire-Revised (CFQ-R) application calculates the score derived from the CFQ-R, on a 0-100 scale with higher scores indicating better HRQoL. |
| Secondary | Evolution of the composition of the bacterial intestinal microbiota | Change from Baseline measurement at 3 months | The composition of the bacterial intestinal microbiota will be assessed by High-throughput sequencing and phylogenetic allocation of the bacterial flora (on MiSeq, from Illumina®) |
| Secondary | Evolution of the composition of the fungal intestinal microbiota | Change from Baseline measurement at 3 months | The composition of the fungal intestinal microbiota will be assessed by high-throughput sequencing and phylogenetic allocation of the fungal flora (on MiSeq, from Illumina®) |
| Secondary | Evolution of the pulmonary inflammation, assessed by the dosage of calprotectin in the sputum | Change from Baseline measurement at 3 months | Evolution of the Pulmonary inflammation will be assessed by measurement of salivary calprotectin (µg / g) by an ELISA biological test between the initiation of treatment (D0) and 3 months of treatment with polyethylene glycol (M3) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 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/NCT04458129
GET https://conductscience.org/api/trials/v1/NCT04458129/registered