Trial Outcomes & Findings for Cystic Fibrosis and Gut Dysmotility: The Effect of Polyethylene Glycol (PEG) on Intestinal Transit (NCT NCT04210427)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

3 participants

Primary outcome timeframe

Change is being assessed: total intestinal transit time (measured in hours) at baseline and two weeks following initiation of therapy with PEG

Results posted on

2024-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention With Polyethylene Glycol & SmartPill Patients will ingest a Smart pill 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. Polyethylene Glycol 3350: All patients will undergo intervention with taking polyethylene glycol (PEG) or Miralax (brand name) 17 grams once daily for total of 2 weeks. SmartPill Motility System \& PillCam Patency Capsule: Patients will ingest a Smart pill to obtain baseline motility within the GI lumen. 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.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention With Polyethylene Glycol & SmartPill n=3 Participants Patients will ingest a Smart pill 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. Polyethylene Glycol 3350: All patients will undergo intervention with taking polyethylene glycol (PEG) or Miralax (brand name) 17 grams once daily for total of 2 weeks. SmartPill Motility System \& PillCam Patency Capsule: Patients will ingest a Smart pill to obtain baseline motility within the GI lumen. 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. Total of 3 patients participated.
Age, Categorical <=18 years	0 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=3 Participants
Age, Categorical >=65 years	0 Participants n=3 Participants
Sex: Female, Male Female	1 Participants n=3 Participants
Sex: Female, Male Male	2 Participants n=3 Participants
Region of Enrollment United States	3 Participants n=3 Participants

PRIMARY outcome

Timeframe: Change is being assessed: total intestinal transit time (measured in hours) at baseline and two weeks following initiation of therapy with PEG

Population: Adult patients with Cystic Fibrosis with gastrointestinal symptoms.

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

Outcome measures

Outcome measures
Measure	Intervention With Polyethylene Glycol & SmartPill n=3 Participants Patients will ingest a Smart pill 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. Polyethylene Glycol 3350: All patients will undergo intervention with taking polyethylene glycol (PEG) or Miralax (brand name) 17 grams once daily for total of 2 weeks. SmartPill Motility System \& PillCam Patency Capsule: Patients will ingest a Smart pill to obtain baseline motility within the GI lumen. 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.
Change is Being Assessed: Total Intestinal Transit Time at Baseline and Two Weeks Following Initiation of Therapy total intestinal transit time-2 weeks after PEG therapy	42 hours Standard Deviation 14
Change is Being Assessed: Total Intestinal Transit Time at Baseline and Two Weeks Following Initiation of Therapy total intestinal transit time - baseline	41 hours Standard Deviation 13

PRIMARY outcome

Timeframe: 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 months prior to diagnosis. Rome 4 IBS absent if not fulfilled as above.

Outcome measures

Outcome measures
Measure	Intervention With Polyethylene Glycol & SmartPill n=3 Participants Patients will ingest a Smart pill 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. Polyethylene Glycol 3350: All patients will undergo intervention with taking polyethylene glycol (PEG) or Miralax (brand name) 17 grams once daily for total of 2 weeks. SmartPill Motility System \& PillCam Patency Capsule: Patients will ingest a Smart pill to obtain baseline motility within the GI lumen. 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.
Number of Participants With IBS at Baseline and 2 Weeks Post Baseline ROME 4 IBS present at 2 weeks after PEG/Smartpill	3 Participants
Number of Participants With IBS at Baseline and 2 Weeks Post Baseline ROME 4 IBS absent at 2 weeks after PEG/Smartpill	0 Participants
Number of Participants With IBS at Baseline and 2 Weeks Post Baseline ROME 4- IBS present at baseline	3 Participants
Number of Participants With IBS at Baseline and 2 Weeks Post Baseline ROME 4- IBS absent at baseline	0 Participants

Adverse Events

Intervention With Polyethylene Glycol & SmartPill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Purnima Modi

Saint Louis University

Phone: 3149772029

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place