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

NCT04210427 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: 30114
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

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.

Conditions

Cystic Fibrosis Gastrointestinal Disease

Keywords

Cystic Fibrosis; Gut Dysmotility; Polyethylene Glycol

Outcome Measures

Primary Outcomes (2)

• Change is Being Assessed: Total Intestinal Transit Time 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 hours.

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

• Number of Participants With IBS at Baseline and 2 Weeks Post Baseline

  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.

  Baseline and 2 weeks

Study Arms (1)

Intervention with polyethylene glycol & SmartPill

EXPERIMENTAL

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; Device: SmartPill Motility System & PillCam Patency Capsule

Interventions

Polyethylene Glycol 3350 DRUG

All patients will undergo intervention with taking polyethylene glycol (PEG) or Miralax (brand name) 17 grams once daily for total of 2 weeks.

Intervention with polyethylene glycol & SmartPill

SmartPill Motility System & PillCam Patency Capsule DEVICE

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.

Intervention with polyethylene glycol & SmartPill

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (2)

SSM Health Cardinal Glennon Children's Hosptial

St Louis, Missouri, 63104, United States

Location

SSM Health Saint Louis University Hosptial

St Louis, Missouri, 63104, United States

Location

Related Publications (7)

• Corral JE, Dye CW, Mascarenhas MR, Barkin JS, Salathe M, Moshiree B. Is Gastroparesis Found More Frequently in Patients with Cystic Fibrosis? A Systematic Review. Scientifica (Cairo). 2016;2016:2918139. doi: 10.1155/2016/2918139. Epub 2016 May 30.

  PMID: 27313953 RESULT

• Hedsund C, Gregersen T, Joensson IM, Olesen HV, Krogh K. Gastrointestinal transit times and motility in patients with cystic fibrosis. Scand J Gastroenterol. 2012 Sep;47(8-9):920-6. doi: 10.3109/00365521.2012.699548. Epub 2012 Jul 2.

  PMID: 22746323 RESULT

• Bentur L, Hino B, Shamir R, Elias N, Hartman C, Eshach-Adiv O, Berkowitz D. Impaired gastric myolectrical activity in patients with cystic fibrosis. J Cyst Fibros. 2006 Aug;5(3):187-91. doi: 10.1016/j.jcf.2006.03.003. Epub 2006 Apr 19.

  PMID: 16627012 RESULT

• Dorsey J, Gonska T. Bacterial overgrowth, dysbiosis, inflammation, and dysmotility in the Cystic Fibrosis intestine. J Cyst Fibros. 2017 Nov;16 Suppl 2:S14-S23. doi: 10.1016/j.jcf.2017.07.014.

  PMID: 28986022 RESULT

• Schappi MG, Roulet M, Rochat T, Belli DC. Electrogastrography reveals post-prandial gastric dysmotility in children with cystic fibrosis. J Pediatr Gastroenterol Nutr. 2004 Sep;39(3):253-6. doi: 10.1097/00005176-200409000-00005.

  PMID: 15319624 RESULT

• Xu RB, Bhuyan RR, Edwards JR. Staged Bentall procedure and extra-anatomical repair of coarctation of aorta. ANZ J Surg. 2016 Apr;86(4):310-1. doi: 10.1111/ans.12666. Epub 2014 May 29. No abstract available.

  PMID: 24891257 RESULT

• Palsson OS, Whitehead WE, van Tilburg MA, Chang L, Chey W, Crowell MD, Keefer L, Lembo AJ, Parkman HP, Rao SS, Sperber A, Spiegel B, Tack J, Vanner S, Walker LS, Whorwell P, Yang Y. Rome IV Diagnostic Questionnaires and Tables for Investigators and Clinicians. Gastroenterology. 2016 Feb 13:S0016-5085(16)00180-3. doi: 10.1053/j.gastro.2016.02.014. Online ahead of print.

  PMID: 27144634 RESULT

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

polyethylene glycol 3350

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Results Point of Contact

• Title: Purnima Modi
• Organization: Saint Louis University

purnima.modi.1@slu.edu

3149772029

Study Officials

• Dhiren Patel, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 24, 2019
• Study Start: December 12, 2019
• Primary Completion: June 6, 2023
• Study Completion: June 6, 2023
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)