Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06199752
Status:
COMPLETED
Last Update Posted:
2024-01-10
First Post:
2023-11-29
Brief Title:
Synergistic Immunomodulatory Effect of Synbiotics Pre and Postoperative Resection of Pancreatic Ductal Adenocarcinoma
Sponsor:
Theodor Bilharz Research Institute
Organization:
Theodor Bilharz Research Institute
Study Overview
Official Title:
Synergistic Immunomodulatory Effect of Synbiotics Pre and Postoperative Resection of Pancreatic Ductal Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PDAC
Brief Summary:
The goal of this interventional study was to evaluate the synergistic effect of symbiotics a combination of probiotics and prebiotics compared to probiotics alone in terms of their impact on anti-tumor immunomodulation in patients with pancreatic ductal adenocarcinoma PDAC The study also aimed to assess the effects of these interventions on postoperative complications and outcomes In the study a probiotic agent Nowfoods USA containing ten strains of bacteria with a total dosage of 25 billion colony-forming units CFU was administered This probiotic regimen involved taking two capsules once daily starting two weeks before the surgery and continuing for one month after the surgery For the synbiotic group in addition to the probiotic agent two capsules per day of inulin supplement HERBAMAMA USA were also taken
The study included three groups the synbiotics group the probiotics group and the placebo group The researchers compared the pathological status of immune cell infiltration specifically CD8 cells and interferon-gamma expression as well as the levels of interleukins 10 6 and 10 in the participants serum Four blood samples were collected from each participant one taken 14 days before the surgery one on the surgery date one two weeks after the surgery and one 30 days after the surgery
The main research question addressed by the study was whether there was a significant difference in the immunomodulatory effect and postoperative complications between the synbiotics group and the probiotics group The placebo group likely served as a control to compare the effects of the interventions against no intervention
The study included three groups the synbiotics group the probiotics group and the placebo group The researchers compared the pathological status of immune cell infiltration specifically CD8 cells and interferon-gamma expression as well as the levels of interleukins 10 6 and 10 in the participants serum Four blood samples were collected from each participant one taken 14 days before the surgery one on the surgery date one two weeks after the surgery and one 30 days after the surgery
The main research question addressed by the study was whether there was a significant difference in the immunomodulatory effect and postoperative complications between the synbiotics group and the probiotics group The placebo group likely served as a control to compare the effects of the interventions against no intervention
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None