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

Theodor Bilharz Research Institute

Status and phase: Completed; Phase 4

Conditions: Pancreatic Ductal Adenocarcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06199752

Synbiotics in cancer

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

90 participants in 3 patient groups, including a placebo group

Placebo

Active Comparator group

Description:

Placebo consisted of identical capsules of powdered glucose polymer

Treatment:

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

Synbiotics group

Placebo Comparator group

Description:

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

Treatment:

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

Probiotics group

Placebo Comparator group

Description:

probiotic agent 25 Billion CFU (Nowfoods, USA)

Treatment:

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