Clinical trial NCT06199752: Synergistic Immunomodulatory Effect of Synbiotics Pre and Postoperative Resection of Pancreatic Ductal Adenocarcinoma
Official title: Synergistic Immunomodulatory Effect of Synbiotics Pre and Postoperative Resection of Pancreatic Ductal Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pancreatic Ductal Adenocarcinoma
Lead sponsor: Theodor Bilharz Research Institute
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Immunohistochemistry testing for immune cells infiltration and interferon-gamma expression
timeFrame: IHC testing for formalin fixed paraffin embedded block for all subjects 10 months from the beginning of the study, as we collected the all samples
measure: Inflammatory cytokines level
timeFrame: 10 months after collection of all blood samples from included subjects
measure: Post-operative -non-infectious complications- improvement
timeFrame: 1-4 weeks post operative
measure: Post-operative -infectious complications improvement
timeFrame: 1-4 weeks post operative
measure: Post-operative improvement days
timeFrame: first day post operative till 20 days
measure: Statistical analysis of the results
timeFrame: 11 months from the beginning of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sara Maher
Study officials:
affiliation: Theodor Bilharz Research Institute
name: Sara Maher
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.