NCT04210427

Cystic Fibrosis and Gut Dysmotility: The Effect of Polyethylene Glycol (PEG) on Intestinal Transit

Completed Phase 4 Results posted Last updated 9 August 2024

What this trial tests

Phase 4 trial testing Polyethylene Glycol 3350 in Cystic Fibrosis Gastrointestinal Disease in 3 participants. Completed in 6 June 2023.

Timeline

12 December 2019

Primary endpoint
6 June 2023

6 June 2023

Quick facts

Lead sponsor	St. Louis University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	12 December 2019
Primary completion	6 June 2023
Estimated completion	6 June 2023
Sites	2 locations across United States

Drugs / interventions tested

• Polyethylene Glycol 3350 — full drug profile →
• SmartPill Motility System & PillCam Patency Capsule

Conditions studied

• Cystic Fibrosis Gastrointestinal Disease — all drugs for Cystic Fibrosis Gastrointestinal Disease →

Sponsor

St. Louis University

Who can join

Adults 18 to 40, any sex, with Cystic Fibrosis Gastrointestinal Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change is Being Assessed: Total Intestinal Transit Time at Baseline and Two Weeks Following Initiation of Therapy Primary · Change is being assessed: total intestinal transit time (measured in hours) at baseline and two weeks following initiation of therapy with PEG

Total intestinal transit time will be measured from the time of ingestion to time of expulsion of smartpill. Unit of measurement will be hours.

total intestinal transit time - baseline

Group	Value	95% CI
Intervention With Polyethylene Glycol & SmartPill	41	± 13

total intestinal transit time-2 weeks after PEG therapy

Group	Value	95% CI
Intervention With Polyethylene Glycol & SmartPill	42	± 14

Number of Participants With IBS at Baseline and 2 Weeks Post Baseline Primary · Baseline and 2 weeks

Subjective assessment for abdominal symptoms with ROME questionnaire. Note that the outcome of these questionnaire is IBS present or absent.Rome 4 is a self-report integrated questionnaire in adults (R4DQ), including alarm symptoms or red flags. ROME 4 IBS present if: Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria: Related to defecation Associated with a change in frequency of stool Associated with a change in form (appearance) of stool Criteria fulfilled for the last 3 months with symptom onset at least 6

ROME 4- IBS present at baseline

Group	Value	95% CI
Intervention With Polyethylene Glycol & SmartPill	3

ROME 4- IBS absent at baseline

Group	Value	95% CI
Intervention With Polyethylene Glycol & SmartPill	0

ROME 4 IBS present at 2 weeks after PEG/Smartpill

Group	Value	95% CI
Intervention With Polyethylene Glycol & SmartPill	3

ROME 4 IBS absent at 2 weeks after PEG/Smartpill

Group	Value	95% CI
Intervention With Polyethylene Glycol & SmartPill	0

Sponsor's own description

The investigators will recruit 15 patients with cystic fibrosis 18 years of age and older who present with constipation. The investigators will assess baseline motility symptoms with a survey. Patients will then ingest a SmartPill (trademark) to obtain baseline motility within the GI lumen. All patients will undergo intervention with taking polyethylene glycol (PEG) or Miralax (brand name) 17 grams once daily. After two weeks of therapy, the patient will repeat the motility survey and again ingest a smart pill to assess the change in motility symptoms while on therapy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.