Significance of highly fermentable dietary fiber in enteral nutrition patients

JRCT ID: jRCT1061230083

Registered date:22/12/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: enteral feeding patient
• Date of first enrollment: 22/12/2023
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Patients who had been receiving low-fiber enteral nutrition for 8 weeks or more were randomly assigned to a high-fermentable dietary fiber granule (PHGG 2g/100kcal) administration group or a control group, and 8 weeks before and after administration of high-fermentable dietary fiber. Evaluate when the time has elapsed.

Outcome(s)

Primary Outcome

Bowel movements: frequency of defecation, stool quality (Bristol scale), number of enema treatments, amount of laxatives used
Intestinal microbiota: short chain fatty acids [SCFA], alpha diversity evaluation

Secondary Outcome

(General findings, etc.)
Age, gender, height, weight, BMI
(Inspection item)
Nutritional indicators: TP, ALB, T-cho, HDL-c, LDL-c, TG, BUN, Cre (e-GFR), UA,
Inflammatory response: hsCRP
Heart failure: NT-proBNP, trimethylamine-N-oxide [TMAO]
Immune ability: TNFA, IL-6

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

1) In principle, over 65 years old and under 90 years old.
Because we wanted to evaluate the effect on elderly people, we selected patients aged 65 and older. Also, the reason why it was chosen to be under 90 years old
This was because it was determined that people over 90 years of age are not eligible for research because it has been shown that there are many metabolites that are associated with the risk of age-related diseases and weaken the intestinal barrier function.
However, if there are not enough research participants, those who wish to participate will be eligible to participate in the research if they are 60 years of age or older.
2) Gender doesn't matter.
3) Patients who are administering enteral nutritional products into the stomach through the nasal passage or gastrostomy.
4) Patients who are hospitalized during the study period.
5) Free consent from the person who has the capacity to consent, or from a representative consenter when the person lacks the capacity to consent.
Patients who can provide written informed consent.

Exclude criteria

1) Patients who do not have permission from their attending physician.
2) Patients with a history of hypersensitivity to dietary fiber.
3) Patients with milk protein allergy.
4) Patients with no residual gastric or intestinal function.
5) Patients with ileus.
6) Patients with severe liver/kidney disorder. (e.g. acute and chronic renal failure, liver cirrhosis, etc.)
7) Patients with glucose metabolism abnormalities such as severe diabetes.
8) Patients with congenital amino acid metabolism abnormalities.
9) Patients with a history of esophagus or stomach resection (minimally invasive surgery such as endoscopic submucosal dissection is excluded)
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10) Patients who have had a history of intestinal resection within one year before consent was obtained (excluding minor cases such as removal of polyps or appendix).
11) Patients who have difficulty collecting the amount of blood necessary for testing.
12) Patients who had a fever of 37.5temperature or higher within 3 days of the start of the study.

Related Information

• Primary Sponsor: Yamamoto Takeshi
• Source(s) of Monetary Support: Research funds for the Department of Pathological Diagnostics, Department of Health Sciences, Graduate School of Medicine, Yamaguchi University