The Protective Role of GABA Stimulation Before Ileostomy Closure

Ileostomy; Complications Clinical Trial

Official title:

The Protective Role of Preoperative Stimulation of the Distal Limb of the Ileostomy Loop With GABA Before Ileostomy Closure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05905393
• Other study ID #: KYLL-202212-066-1
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2023
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: Qilu Hospital of Shandong University
• Contact: Wei Guo, Dr.
• Phone: 0086-18560089725
• Email: wguo[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to explore whether preoperative stimulation of the distal limb of the ileostomy loop with gamma aminobutyric acid (GABA) could effectively reduce the incidence of complications after ileostomy closure. Participants will be divided into two groups. One group included patients treated with stimulation of the efferent loop with GABA prior to transit reconstruction surgery; the other control group was stimulated without giving any substance. Researchers will compare incidence of complications such as postoperative ileus, diarrhea and other parameters such as time to tolerating a diet, start of the passage of flatus, start of the passage of stool, postoperative stay, etc.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• over 18 years of age;
• body mass index (BMI) 18.5-28 kg/m2;
• having protective ileostomy after colorectal carcinoma surgery free of disease;
• with endoscopic and histological confirmation of diversion colitis;
• no oral antibiotics within 3 months;
• having signed the informed consent.

Exclusion Criteria:

• under 18 years of age;
• clinical history, and histological confirmation of inflammatory bowel disease with colorectal involvement;
• history of neoadjuvant or adjuvant chemoradiotherapy;
• other serious chronic diseases, such as cardiovascular and cerebrovascular diseases, diabetes, respiratory diseases, etc;
• serious perioperative complications such as anastomotic rupture after surgery;
• oral antibiotics within three months;
• participation in any other studies within the past 3 months.

Related Conditions & MeSH terms

• Ileostomy; Complications

Intervention

Dietary Supplement:
• preoperative stimulation of the efferent loop with GABA before ileostomy closure surgery
Foley catheter No.14 Ch connected to an infusion set was introduced through the defunctioned bowel to allow the slow infusion, for 10-20 minutes, of a solution with 3000 mg of GABA diluted in 100 ml of 0.9% physiological saline.
• preoperative stimulation of the efferent loop with only physiological saline
Foley catheter No.14 Ch connected to an infusion set was introduced through the defunctioned bowel to allow the slow infusion, for 10-20 minutes, of 100 ml of 0.9% physiological saline.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

References & Publications (10)

Bansal P, Wang S, Liu S, Xiang YY, Lu WY, Wang Q. GABA coordinates with insulin in regulating secretory function in pancreatic INS-1 beta-cells. PLoS One. 2011;6(10):e26225. doi: 10.1371/journal.pone.0026225. Epub 2011 Oct 21. — View Citation

Beamish EL, Johnson J, Shaw EJ, Scott NA, Bhowmick A, Rigby RJ. Loop ileostomy-mediated fecal stream diversion is associated with microbial dysbiosis. Gut Microbes. 2017 Sep 3;8(5):467-478. doi: 10.1080/19490976.2017.1339003. Epub 2017 Jun 16. — View Citation

Garfinkle R, Savage P, Boutros M, Landry T, Reynier P, Morin N, Vasilevsky CA, Filion KB. Incidence and predictors of postoperative ileus after loop ileostomy closure: a systematic review and meta-analysis. Surg Endosc. 2019 Aug;33(8):2430-2443. doi: 10.1007/s00464-019-06794-y. Epub 2019 Apr 17. — View Citation

Matthiessen P, Hallbook O, Rutegard J, Simert G, Sjodahl R. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg. 2007 Aug;246(2):207-14. doi: 10.1097/SLA.0b013e3180603024. — View Citation

Rodriguez-Padilla A, Morales-Martin G, Perez-Quintero R, Gomez-Salgado J, Balongo-Garcia R, Ruiz-Frutos C. Postoperative Ileus after Stimulation with Probiotics before Ileostomy Closure. Nutrients. 2021 Feb 15;13(2):626. doi: 10.3390/nu13020626. — View Citation

Rombey T, Panagiotopoulou IG, Hind D, Fearnhead NS. Preoperative bowel stimulation prior to ileostomy closure to restore bowel function more quickly and improve postoperative outcomes: a systematic review. Colorectal Dis. 2019 Sep;21(9):994-1003. doi: 10.1111/codi.14636. Epub 2019 May 7. — View Citation

Soltani N, Qiu H, Aleksic M, Glinka Y, Zhao F, Liu R, Li Y, Zhang N, Chakrabarti R, Ng T, Jin T, Zhang H, Lu WY, Feng ZP, Prud'homme GJ, Wang Q. GABA exerts protective and regenerative effects on islet beta cells and reverses diabetes. Proc Natl Acad Sci U S A. 2011 Jul 12;108(28):11692-7. doi: 10.1073/pnas.1102715108. Epub 2011 Jun 27. — View Citation

Strandwitz P, Kim KH, Terekhova D, Liu JK, Sharma A, Levering J, McDonald D, Dietrich D, Ramadhar TR, Lekbua A, Mroue N, Liston C, Stewart EJ, Dubin MJ, Zengler K, Knight R, Gilbert JA, Clardy J, Lewis K. GABA-modulating bacteria of the human gut microbiota. Nat Microbiol. 2019 Mar;4(3):396-403. doi: 10.1038/s41564-018-0307-3. Epub 2018 Dec 10. — View Citation

Wang S, Sui S, Liu Z, Peng C, Liu J, Luo D, Fan X, Liu C, Lu WY. Protective roles of hepatic gamma-aminobutyric acid signaling in acute ethanol exposure-induced liver injury. J Appl Toxicol. 2018 Mar;38(3):341-350. doi: 10.1002/jat.3544. Epub 2017 Oct 17. — View Citation

Wang S, Xiang YY, Zhu J, Yi F, Li J, Liu C, Lu WY. Protective roles of hepatic GABA signaling in acute liver injury of rats. Am J Physiol Gastrointest Liver Physiol. 2017 Mar 1;312(3):G208-G218. doi: 10.1152/ajpgi.00344.2016. Epub 2016 Dec 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of complications after ileostomy closure	postoperative ileus, diarrhea, time to tolerating a diet, start of the passage of flatus, start of the passage of stool, postoperative stay.	From date of randomization until the date of discharge, assessed up to 20 days
Secondary	glucose metabolism-related parameters	Insulin, C peptide	From date of randomization until the date of discharge, assessed up to 20 days
Secondary	microbiota alteration	microbiota alteration before and after GABA stimulation	From date of randomization until the date of discharge, assessed up to 20 days
Secondary	metabolite alteration	metabolite alteration before and after GABA stimulation	From date of randomization until the date of discharge, assessed up to 20 days