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

NCT ID: NCT06199752

Last Updated: 2024-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-12
• Study Completion Date: 2023-09-10

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Placebo

Placebo consisted of identical capsules of powdered glucose polymer

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DIETARY_SUPPLEMENT

probiotic agent 25 Billion CFU (Nowfoods, USA), composed of ten strains of bacteria (Lactobacillus acidophilus, Bifidobacterium lactis, Lactobacillus plantaLactobacillus paracasei, Bifidobacterium breve, Streotococcus thermophiles, Lactobacillus salivarius, and Bifidobacterium longum),

Synbiotics group

probiotic agent 25 Billion CFU (Nowfoods, USA), + Inulin capsules 1000mg two capsules once daily. Herbamama USA

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: DIETARY_SUPPLEMENT

probiotic agent 25 Billion CFU (Nowfoods, USA), composed of ten strains of bacteria (Lactobacillus acidophilus, Bifidobacterium lactis, Lactobacillus plantaLactobacillus paracasei, Bifidobacterium breve, Streotococcus thermophiles, Lactobacillus salivarius, and Bifidobacterium longum),

Probiotics group

probiotic agent 25 Billion CFU (Nowfoods, USA)

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: DIETARY_SUPPLEMENT

probiotic agent 25 Billion CFU (Nowfoods, USA), composed of ten strains of bacteria (Lactobacillus acidophilus, Bifidobacterium lactis, Lactobacillus plantaLactobacillus paracasei, Bifidobacterium breve, Streotococcus thermophiles, Lactobacillus salivarius, and Bifidobacterium longum),

Interventions

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

probiotic agent 25 Billion CFU (Nowfoods, USA), composed of ten strains of bacteria (Lactobacillus acidophilus, Bifidobacterium lactis, Lactobacillus plantaLactobacillus paracasei, Bifidobacterium breve, Streotococcus thermophiles, Lactobacillus salivarius, and Bifidobacterium longum),

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Patients with primary PDAC with complete pathological and follow-up data
• Patients without long-distance metastasis
• Patients without chronic diseases
• Patients without any treatments before the surgery.

Exclusion Criteria

• Patients who suffered from other tumors or other chronic diseases or accidentally died
• Lack of pathological and follow-up data.
• Patients with long-distance metastasis before the surgery.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theodor Bilharz Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Maher Sara

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara Maher

Role: PRINCIPAL_INVESTIGATOR

Theodor Bilharz Research Institute

Locations

Sara Maher

Cairo, , Egypt

Countries

Egypt

References

Sobocki BK, Kazmierczak-Siedlecka K, Folwarski M, Hawrylkowicz V, Makarewicz W, Stachowska E. Pancreatic Cancer and Gut Microbiome-Related Aspects: A Comprehensive Review and Dietary Recommendations. Nutrients. 2021 Dec 10;13(12):4425. doi: 10.3390/nu13124425.

Reference Type: BACKGROUND

PMID: 34959977 (View on PubMed)

Maher S, Elmeligy HA, Aboushousha T, Helal NS, Ossama Y, Rady M, Hassan AMA, Kamel M. Synergistic immunomodulatory effect of synbiotics pre- and postoperative resection of pancreatic ductal adenocarcinoma: a randomized controlled study. Cancer Immunol Immunother. 2024 Apr 25;73(6):109. doi: 10.1007/s00262-024-03686-6.

Reference Type: DERIVED

PMID: 38662232 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Synbiotics in cancer

Identifier Type: -

Identifier Source: org_study_id