Trial · NCT07569419
Proof of Principle Study for an Efficacy Trial of Linaclotide for Cystic Fibrosis
NCT07569419, Early phase 1, Recruiting, University of Nottingham
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Proof of Principle Study for an Efficacy Trial of Linaclotide for Cystic Fibrosis. Trials, record NCT07569419. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07569419
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Proof of Principle Study for an Efficacy Trial of Linaclotide for Cystic Fibrosis
- NCT number
- NCT07569419
- Status
- Recruiting
- Phases
- Early phase 1
- Enrollment
- 26 participants, estimated
- Lead sponsor
- University of Nottingham
- Conditions
- Cystic Fibrosis (CF)
- Interventions
- Linaclotide 290 micrograms, Lactose placebo pill
- First posted
- 2026-05-06
- Last updated
- 2026-05-06
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Small bowel water content | Baseline, and 0, 60, 120, 180, 240, 300, 360 minutes post-dose | Area under curve (AUC) 0-360 minutes Water content in small bowel as assessed by MRI (mL) |
| Secondary | Colon water content | Baseline, and 0, 60, 120, 180, 240, 300, 360 minutes post-dose | Area under curve (AUC) 0-360 min Water content in the ascending colonic region as assessed by MRI (mL) |
| Secondary | Colonic regional segmental volumes | Baseline, and 0, 60, 120, 180, 240, 300, 360 minutes post-dose | Total volume of regional colonic segments (ascending, transverse, descending, sigmorectal) as assessed by MRI (mL) at each time point. |
| Secondary | Changes in stool consistency | 2 days before intervention, 5 days post-intervention | Stool consistency rated using Bristol stool scale (type 1-7; 7 being watery stool). |
| Secondary | Changes in whole gut transit time (WGTT) | 1 day post-intervention | Assessed by time to stool discolouration following administration of blue dye paste. |
| Secondary | Gastrointestinal symptom rating | 2 days pre-intervention and 5 days post-intervention | Assessing the severity of common gastrointestinal symptoms (flatulence / gas passage, diarrhoea / loose stool, bloating, abdominal pain) via Likert-type scale: 0 = not at all 1. = mild (distinct but negligible) 2. = moderate (annoying) 3. = severe (disabling |
| Secondary | Changes in stool frequency | 2 days before starting intervention and for 5 days post intervention | Frequency (per day) of bowel movements (number with exact time) |
| Secondary | Small bowel motility | Baseline, and 0, 60, 120, 180, 240, 300, 360 minutes post-dose | Maximum motility score (A.U) of the small bowel as assessed by MRI |
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.
Papers18
The papers the trial lists on ClinicalTrials.gov.
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/NCT07569419
GET https://conductscience.org/api/trials/v1/NCT07569419/registered