Those Probiotics May Actually Be Hurting Your ‘Gut Health’

A very readable article in the Wall Street Journal: Those Probiotics May Actually Be Your ‘Gut Health’ –may be behind a paywall. (Thanks to Ben Enav for sharing)

This study makes the following key points:

  • “In a landmark paper by my colleague Dr. Jennifer Wargo at the University of Texas MD Anderson Cancer Center that was published in Science last year, melanoma patients with the healthiest gut microbiomes—that is, the greatest diversity of microorganisms—showed enhanced systemic and antitumor immunity as well as significantly increased odds of responding to immunotherapy.”
  • “The preliminary results [from an MD Anderson Study] showed that patients who reported taking an over-the-counter probiotic supplement had a lower probability of responding to immunotherapy as well as lower microbiome biodiversity. But those eating a high-fiber diet were about five times more likely to respond to immunotherapy and had high gut bacteria diversity, including bacteria previously linked to a strong immunotherapy response.”
  • “The cheapest and safest way to improve our microbiome and gut health is to make simple dietary changes to feed the development of good bacteria and crowd out the bad. There is no pill, special food, unique diet or quick fix for what ails our health and diet. The key is simply to focus on eating a diverse, whole-food, plant-centered, high-fiber diet.”

More information on studies alluded to above:

Related blog posts:

#NASPGHAN19 Selected Abstracts (Part 1)

Link to full NASPGHAN 2019 Abstracts.

Here are some abstracts that I found interesting at this year’s NASPGHAN meeting:

NAFLD:

  1. Off-label use of topiramate may be helpful in stabilizing weight and improving NAFLD
  2. Socioeconomic barriers are frequent in NAFLD patients (the 2nd poster did not appear to show a control population):

Primary Sclerosing Cholangitis -Use of Vedolizumab for PSC did not appear to help

Eosinophilic Esophagitis

  1. EoE is four times more likely in this cohort with inflammatory bowel disease
  2. 2nd poster describes very early-onset EoE

Inflammatory Bowel Disease:

  1. Use of infliximab in VEO IBD.  Used in 46/122 (38% of patients) and 50% had persistent use 3 years later

Enteral nutrition –poster from our group describing good tolerance of plant-based formula (with Ana Ramirez).

Celiac disease.  This poster indicates low yield of additional serology for celiac disease besides TTG IgA and serum IgA. This includes testing in young patients (< 2 years) with celiac disease.

Food-borne Outbreaks and Lack of FDA Transparency

A recent opinion piece from FoodSafetyNews highlights the lack of transparency from the FDA regarding food-borne outbreaks (several more listed below).

Bill Marler: Publisher’s Platform: A bit more about the FDA and lack of Transparency

Here’s an excerpt:

The Halloween disclosure of a multistate E. coli outbreak linked to romaine lettuce raises another concern about the FDA and transparency — the failure to disclose where consumers purchased the tainted product..

Under the Freedom of Information Act and Title 21 of the Code of Regulations, government agencies — and specifically, the FDA — are told to exempt trade secrets and commercial information from any of their releases…

Formulations, ingredients and how products are made are trade secrets.  Who supplied the tainted raw material, who made the tainted product and where the tainted product was sold are not a trade secrets – especially during an outbreak.  Simplicity, transparency and consistency allows for a visible supply chain and one that consumers can have confidence in. 

Recent outbreaks (thanks to colleague for these references):

Multistate Salmonella Outbreak Linked To Ground Beef Causes One Death, Eight Hospitalizations

  • Reuters (11/1, Maddipatla) reported, “A multistate outbreak of salmonella linked to ground beef has caused one death in California and eight hospitalizations, U.S. health officials said on Friday. A total of 10 people in six U.S. states were infected with a strain of the bacteria called Salmonella Dublin, according to the Centers for Disease Control and Prevention.”
  • TIME (11/2, Carlisle) reported, “Officials have not yet identified a single common source of the ground beef that is believed to be spreading the Salmonella Dublin based on epidemiological and laboratory evidence. According to the CDC, the sick individuals reported eating different brands of ground beef at different locations.”
  • CNN (11/1, Christensen) also reported the story.

Previously Undisclosed E. Coli Outbreak Linked To Romaine Lettuce Sickened Nearly Two Dozen People, FDA Says

  • The Washington Post (11/1, Brice-Saddler) reported, “A previously undisclosed E. coli outbreak linked to romaine lettuce sickened nearly two dozen people between July and early September, the Food and Drug Administration said Thursday – a delayed announcement one food safety lawyer called a ‘lie to the public in all respects.’” The piece added, “Illnesses associated with the outbreak infected 23 people across 12 states from July 12 to Sept. 8, according to the FDA. No patients died of their illnesses, and officials say there is no ongoing public health risk.”

Dozens more fresh vegetable products because of Listeria monocytogenes risk (11/4) (FoodSafetyNews.com)

  • A (Canadian) nationwide recall of freshcut vegetables continues to expand with dozens of products and multiple brands now on the list. Products potentially contaminated with Listeria monocytogenes are cole slaw, riced cauliflower, green beans, noodles, kale salads and more.  Some of the products do not expire for 10 days or more, so consumers and businesses are urged to check their supplies for the recalled products listed here by the Canadian government

My take: Food-borne illnesses cause 48 million cases in U.S. each year (CDC estimates) and 3000 deaths (MMWR 64:2, 2015). More transparency is needed.

Related blog post: Food Safety Lecture-It’s Still A Jungle Out There

 

Prevalence of Bloodstream Infections in Children with SBS and Fever

Abstract Link: Prevalence of Bloodstream Infections in Children With Short‐Bowel Syndrome With a Central Line Presenting to Emergency Department With Fever

AC Fifi et al JPEN; https://doi.org/10.1002/jpen.1701

This retrospective study with 246 encounters identified the rate of bloodstream infections (BSI) in children with short bowel syndrome (SBS).

Key findings:

  • The adjusted calculated prevalence rate for BSI in children with SBS and fever was 55% (95% CI, 42.3%–65.4%)
  • There were 114 gram‐negative infections (72.6%), 46 gram‐positive infections (29.3%), and 17 fungal infections (10.8%)
  • Each additional 10 units above 20 mg/L CRP increased the odds of BSI by 26%. There was no association between WBC count and the presence of BSI

My take: This study supports the practice of using broad‐spectrum antibiotics in children with SBS and fever.

Related blog posts:

Atlanta Botanical Garden

In the News, New Cystic Fibrosis Study

More information related to today’s earlier post: In the News: Big Therapeutic Advance for Cystic Fibrosis

Abstract

BACKGROUND

Cystic fibrosis is caused by mutations in the gene encoding the cystic fibrosis transmembrane conductance regulator (CFTR) protein, and nearly 90% of patients have at least one copy of the Phe508del CFTR mutation. In a phase 2 trial involving patients who were heterozygous for the Phe508del CFTR mutation and a minimal-function mutation (Phe508del–minimal function genotype), the next-generation CFTR corrector elexacaftor, in combination with tezacaftor and ivacaftor, improved Phe508del CFTR function and clinical outcomes.

METHODS

We conducted a phase 3, randomized, double-blind, placebo-controlled trial to confirm the efficacy and safety of elexacaftor–tezacaftor–ivacaftor in patients 12 years of age or older with cystic fibrosis with Phe508del–minimal function genotypes. Patients were randomly assigned to receive elexacaftor–tezacaftor–ivacaftor or placebo for 24 weeks. The primary end point was absolute change from baseline in percentage of predicted forced expiratory volume in 1 second (FEV1) at week 4.

RESULTS

A total of 403 patients underwent randomization and received at least one dose of active treatment or placebo. Elexacaftor–tezacaftor–ivacaftor, relative to placebo, resulted in a percentage of predicted FEV1 that was 13.8 points higher at 4 weeks and 14.3 points higher through 24 weeks, a rate of pulmonary exacerbations that was 63% lower, a respiratory domain score on the Cystic Fibrosis Questionnaire–Revised (range, 0 to 100, with higher scores indicating a higher patient-reported quality of life with regard to respiratory symptoms; minimum clinically important difference, 4 points) that was 20.2 points higher, and a sweat chloride concentration that was 41.8 mmol per liter lower (P<0.001 for all comparisons). Elexacaftor–tezacaftor–ivacaftor was generally safe and had an acceptable side-effect profile. Most patients had adverse events that were mild or moderate. Adverse events leading to discontinuation of the trial regimen occurred in 1% of the patients in the elexacaftor–tezacaftor–ivacaftor group.

CONCLUSIONS

Elexacaftor–tezacaftor–ivacaftor was efficacious in patients with cystic fibrosis with Phe508del–minimal function genotypes, in whom previous CFTR modulator regimens were ineffective. (Funded by Vertex Pharmaceuticals; VX17-445-102 ClinicalTrials.gov number, NCT03525444. opens in new tab.)

In the News: Big Therapeutic Advance for Cystic Fibrosis

Washington Post: Long-Awaited Drug Could Turn Deadly Disease into Manageable Condition

An excerpt:

A new cystic fibrosis therapy dramatically improved patients’ lung function and showed clear signs of targeting the genetic root of the disease, instead of just alleviating symptoms — a breakthrough so long-sought that many doctors and patients are moved to tears when talking about it.

The data, being unveiled Thursday at a national conference in Tennessee and simultaneously published in two leading medical journals, was so persuasive that the Food and Drug Administration last week approved the three-drug combination, called Trikafta — five months ahead of the agency’s deadline. The drug could benefit 90 percent of patients with the disease, a major advance over previous drugs that worked in a tiny fraction of the people with the disease or had more modest effects

Sarah Carollo, 28, a special needs teacher in Lee’s Summit, Mo., started Trikafta through a clinical trial in late 2018. Carollo… couldn’t walk down a hallway without stopping to rest and catch her breath…

A few days after she began taking the pill, her doctors tested her lung function and were so stunned at the improvement that they had to check whether they were really looking at the results from the right patient. Two weeks ago, Carollo ran a 5K race with another patient, Laurana Blackburn, who was also taking the drug through the clinical trial…

There are more than 1,700 gene mutations that can cause the protein to malfunction, but in the most common mutation, the protein is misfolded and can’t reach the right spot in the cell — and even if it does reach that spot, it doesn’t work properly. The new combination therapy includes one drug that corrects the misfolded protein and two that activate the correctly folded protein when it reaches the right spot in the cell.

In the largest trial, reported in the New England Journal of Medicine, 403 patients who had at least one copy of the most common gene mutation underlying cystic fibrosis received either Trikafta or a placebo. There were improvements in objective tests of lung function, decreases in lung problems and hospitalizations and an increase in people’s quality of life…

It also remains to be seen whether patients have an easy time gaining access to the drug, which will cost $311,000 a year. While that is a tremendous amount, orphan drugs for small patient populations typically carry very large price tags, and physicians are optimistic that insurers will cover the drug.

The NY Times reported on the FDA approval (October 2019), Studies Yield ‘Impressive’ Results in Fight Against Cystic Fibrosis, and noted that the “Institute for Clinical and Economic Review, which evaluates the cost-effectiveness of drugs, found that the cystic fibrosis drugs the company sells should cost as much as 77 percent less. ”