NCT06199752: PDAC

Synergistic Immunomodulatory Effect of Synbiotics Pre and Postoperative Resection of Pancreatic Ductal Adenocarcinoma

Completed Phase 4 Last updated 10 January 2024

What this trial tests

Phase 4 trial testing probiotic agent 25 Billion CFU (Nowfoods, USA) , ). Inulin capsules 1000mg Herbamama USA in Pancreatic Ductal Adenocarcinoma in 90 participants. Completed in 10 September 2023.

Timeline

12 December 2021

Primary endpoint
20 April 2023

10 September 2023

Quick facts

Lead sponsor	Theodor Bilharz Research Institute
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	90
Start date	12 December 2021
Primary completion	20 April 2023
Estimated completion	10 September 2023
Sites	1 location across Egypt

Drugs / interventions tested

• probiotic agent 25 Billion CFU (Nowfoods, USA) , ). Inulin capsules 1000mg Herbamama USA

Conditions studied

• Pancreatic Ductal Adenocarcinoma — all drugs for Pancreatic Ductal Adenocarcinoma →

Sponsor

Theodor Bilharz Research Institute

Who can join

Adults 25 to 65, any sex, with Pancreatic Ductal Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Unveiling the resistance to therapies in pancreatic ductal adenocarcinoma.
   Shah A, Ganguly K, Rauth S, Sheree SS, et al · · 2024 · cited 14× · PMID 39243602 · DOI 10.1016/j.drup.2024.101146
2. Synergistic immunomodulatory effect of synbiotics pre- and postoperative resection of pancreatic ductal adenocarcinoma: a randomized controlled study.
   Maher S, Elmeligy HA, Aboushousha T, Helal NS, et al · · 2024 · cited 13× · PMID 38662232 · DOI 10.1007/s00262-024-03686-6
3. Role of Probiotics in Enhancing Immune Function and Improving the Effectiveness of Treatments for Pancreatic Cancer.
   Kaur K. · · 2025 · PMID 41471890 · DOI 10.3390/microorganisms13122687