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

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ClinicalTrials.gov Identifier: NCT04210427
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Dhiren Patel, MD, St. Louis University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Gastrointestinal Disease Drug: Polyethylene Glycol 3350 Device: SmartPill Motility System & PillCam Patency Capsule Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cystic Fibrosis and Gut Dysmotility: The Effect of Polyethylene Glycol (PEG) on Intestinal Transit
Actual Study Start Date : December 12, 2019
Estimated Primary Completion Date : June 13, 2021
Estimated Study Completion Date : August 13, 2021


Arm Intervention/treatment
Experimental: 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.
Drug: 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.

Device: 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.




Primary Outcome Measures :
  1. Change is being assessed: total intestinal transit time at baseline and two weeks following initiation of therapy [ Time Frame: Change is being assessed: total intestinal transit time (measured in hours) at baseline and two weeks following initiation of therapy ]
    Total intestinal transit time will be measured from the time of ingestion to time of expulsion of smartpill. Unit of measurement will be hour.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • previously diagnosed with CF confirmed with genetic mutations consistent with CF
  • greater than 18 years old who chose to participate in the research study
  • have symptoms of constipation (constipation will be defined as stool frequency less than three times per week, Bristol stool scale form 1-2 in >25% of stools, and/or the sensation of incomplete evacuation, manual maneuvers to facilitate stools, and the sensation of blockage)

The patients enrolled are allowed to be on CFTR modulating drugs and/or receiving enteral feeding.

Exclusion Criteria:

  • minors (<18 years old)
  • active nicotine use or patients on nicotine replacement
  • history of abdominal surgery (surgeries involving gastrointestinal luminal resection) ie small bowel or colonic resection that increases risk of post-operative strictures or narrowing of the lumen. Surgeries such as Nissen fundoplication, gastrostomy tube placement, gynecologic surgeries, appendectomy, and/or cholecystectomy are not excluded from this study.
  • history of diabetes
  • history of lung transplantation or pancreas transplant
  • BMI >40
  • pregnancy (this will be screened via urine pregnancy test)
  • incarcerated persons
  • patients with DIOS (distal intestinal obstructive syndrome)
  • patients with known hypersensitivity to PEG
  • persons unable to remain off the contraindicated medications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04210427


Contacts
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Contact: Dhiren Patel, MD 314-577-5647 dhiren.patel@health.slu.edu
Contact: Elizabeth V Marsicano, MD 314-577-8764 elizabeth.marsicano@health.slu.edu

Locations
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United States, Missouri
SSM Health Cardinal Glennon Children's Hosptial Recruiting
Saint Louis, Missouri, United States, 63104
Contact: Dhiren Patel, MD    314-577-5647    dhiren.patel@health.slu.edu   
SSM Health Saint Louis University Hosptial Recruiting
Saint Louis, Missouri, United States, 63104
Contact: Dhiren Patel, MD    314-577-5647    dhiren.patel@health.slu.edu   
Contact: Elizabeth Marsicano, MD    314-577-8764    elizabeth.marsicano@health.slu.edu   
Sponsors and Collaborators
St. Louis University
Investigators
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Principal Investigator: Dhiren Patel, MD St. Louis University
Publications of Results:

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Responsible Party: Dhiren Patel, MD, Assistant Professor, St. Louis University
ClinicalTrials.gov Identifier: NCT04210427    
Other Study ID Numbers: 30114
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dhiren Patel, MD, St. Louis University:
Cystic Fibrosis
Gut Dysmotility
Polyethylene Glycol
Additional relevant MeSH terms:
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Cystic Fibrosis
Gastrointestinal Diseases
Digestive System Diseases
Fibrosis
Pathologic Processes
Pancreatic Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Polyethylene glycol 3350
Laxatives
Gastrointestinal Agents